The primary tumor in the lung must be biopsy confirmed non-small cell lung cancer within 180 days of randomization
Part 2B: Patient with Non-Small Cell Lung Cancer (NSCLC), Endometrial cancers, and MSI-H solid tumors.
Advanced Non Small Cell Lung Cancer (NSCLC)
No prior radiotherapy or chemotherapy (except for the chemotherapy described in the bullet above) for small cell lung cancer (SCLC)
Pathologically confirmed non-squamous non-small cell lung carcinoma (NSCLC)
Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC)
Patient has one of the following histologically or cytologically confirmed advanced malignancies: acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), glioblastoma multiforme (GBM), melanoma, non-small cell lung cancer (NSCLC), ovarian cancer, pancreatic cancer, sarcoma, renal cell carcinoma (RCC)
Small cell lung cancer (SCLC).
Non-small cell lung cancer (NSCLC)
Small cell lung cancer (SCLC)
Non-small cell lung cancer (NSCLC) (adenocarcinoma)
Participants with unilateral pleural effusion (other than non-small cell lung cancer [NSCLC] indication) should fulfill the following criteria for pulmonary and cardiac functions: Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification 0 ? 1 level and New York Heart Association (NYHA) classification class 1
Non-small cell lung adenocarcinoma or squamous cell carcimona
Eligible disease sites include the following\r\n* Breast\r\n* Prostate\r\n* Gastrointestinal (GI) (including colorectal, anal, esophagus, pancreas, gastric with the exception of patients with colon cancer and liver-only metastatic disease)\r\n* Head and neck\r\n* Skin (melanoma and squamous cell carcinoma)\r\n* Lung (both small cell and non-small cell)\r\n* Sarcoma (both soft tissue and bone)\r\n* Gynecologic (endometrial, cervical, ovarian, vaginal, vulvar)
Eligible disease sites include the following\r\n* Breast\r\n* Prostate\r\n* Gastrointestinal (GI) (including colorectal, anal, esophagus, pancreas, gastric with the exception of colon cancer with resectable liver-only lesions)\r\n* Head and neck\r\n* Skin (melanoma and squamous cell carcinoma)\r\n* Lung (both small cell and non-small cell)\r\n* Sarcoma (both soft tissue and bone)\r\n* Gynecologic (endometrial, cervical, ovarian, vaginal, vulvar)
Non-small cell lung carcinoma;
Patients must have a known diagnosis of either metastatic castration-resistant prostate cancer (mCRPC) or non-small cell lung cancer (NSCLC) with evidence of measurable disease.
Small cell lung cancer
Participants with small cell lung cancer, lymphoma, or myeloma
Patients with prior history of either small cell lung cancer or NSCLC regardless of the treatment received, other than patients who have recurrent disease following resection
Small Cell Lung Carcinoma
Diagnostic of small cell lung cancer
Histologic diagnosis of a non-small cell lung cancer or lung metastasis from a solid tumor; one biopsy site is adequate for multiple sites of thoracic disease
Small cell lung cancer (SCLC).
Component of small-cell cancer or sarcomatoid cancer
Confirmed locally advanced and/or metastatic solid tumor, with at least one tumor lesion of non-critical location accessible to biopsy (with exception of non-small cell lung cancer [NSCLC] participants), and with confirmed progression at baseline that has progressed on, or participant is intolerant to, the standard of care therapy
Pathologically confirmed invasive non-small cell lung cancer within 12 weeks prior to study registration. OR Pathologically confirmed invasive non-small cell lung cancer within 6 months prior to study registration if the patient received induction chemotherapy.
Expansion cohort B, groups 1, 2, 3, 4, 5, 6 and 7: Patients must have advanced pathologically proven mutant KRAS non-small cell lung cancer (group 1), pancreatic cancer (group 2; documentation of KRAS mutation not required), mutant KRAS colorectal cancer (group 3), head and neck squamous cell carcinoma (group 4), mesothelioma (group 5), hepatocellular cancer (group 6), and biliary carcinoma (group 7)
COHORT B GROUP 1: NON-SMALL CELL LUNG CANCER: Patients must have advanced non-small cell lung cancer with mutant KRAS
COHORT B GROUP 1: NON-SMALL CELL LUNG CANCER: Patients must have failed a minimum of one previous line of chemotherapy for advanced disease
COHORT B, GROUP 1: NON-SMALL CELL LUNG CANCER: Patients must not have clinical significant hemoptysis
Limited primary non-small cell lung cancers (NSCLCs) (T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0) or metastatic lung tumors with no evidence of uncontrolled extrathoracic metastases
Biopsy-proven non-hematopoietic malignancy, except for germ cell cancer. Small cell lung carcinoma is eligible for this study.
All subjects must have history of histologically confirmed small cell lung cancer. Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician
Greater than 2 lines of prior systemic therapy for metastatic non-small cell lung cancer
Prior treatment with osimertinib or other drugs that target EGFR mutant non-small cell lung cancer (including erlotinib, afatinib, gefitinib, rocelitinib)
For the dose expansion phase: Patients with locally advanced unresectable or metastatic, non-small cell lung cancer (NSCLC), castration-resistant prostate cancer (CRPC) and pancreatic ductal adenocarcinoma (PDAC)
Measurable solid cancer with at least one lesion that is resectable for tumor infiltrating lymphocytes (TIL) generation with minimal morbidity plus at least one other lesion that can be measured that falls into one of four cohorts:\r\n* Gastrointestinal and genitourinary cancers\r\n* Breast and ovarian, and other solid cancers\r\n* Lung cancer (Non-small cell lung cancer ([NSCLC])\r\n* Glioblastoma\r\n** Note: Metastatic disease is required for cohorts 1-3, but not required for cohort 4\r\n** Note: NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas; neuroendocrine tumors are not eligible
Histologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:
Histologically or cytologically confirmed non-small cell lung cancer; if a diagnostic biopsy is available, a pre-treatment biopsy is not required. Patients with a suspected lung cancer may be consented, but pathology must be confirmed prior to initiating treatment on study. Neuroendocrine carcinomas (e.g. small cell lung cancer [SCLC], carcinoid tumors) are not eligible. Carcinomas with neuroendocrine differentiation are eligible.
Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC)
Has metastatic non-small cell lung cancer
Newly diagnosed, untreated, biopsy proven non-small cell lung cancer
Patients with metastatic or node positive non-small cell lung cancer (NSCLC)
Histological confirmation of non-small cell lung cancer
Unresectable stage 2-3 non-small cell lung cancer (based on computed tomography/positron emission tomography [CT/PET], magnetic resonance imaging [MRI] or CT of brain, and physical exam);\r\n* Eligible if recurrence after surgery and now has the equivalent stage 2-3 non-small cell lung cancer (NSCLC) OR had sub totally resected stage 2-3 NSCLC
Histologic/cytologic documentation of non-small cell lung cancer (NSCLC)
Histological or cytological evidence of stage IV non-small cell lung cancer (NSCLC) (any histology)
Arm A dose level 4 (75 mg/m^2 cisplatin): patients with histologically proven chemotherapy-naive advanced unresectable solid tumors for which pemetrexed combined with cisplatin is an indicated regimen (malignant mesothelioma, non-small cell lung cancer, ovarian cancer and thymoma)
Has a histological confirmation of pancreatic cancer, mismatch deficient colorectal cancer, or non-small cell lung cancer (NSCLC) that is refractory to standard therapy or for which no standard of care regimen currently exists
Has a pathologically proven recurrent or metastatic non-squamous non-small cell lung cancer
Patients may not be receiving any other investigational agents for the treatment of non-small cell lung cancer
Patients with pathologically proven non-small cell lung cancer
Diagnosis with a histologically confirmed non-small cell lung cancer (NSCLC) or other refractory solid tumor that is metastatic or unresectable for which there is no standard curative or palliative treatment option available and where targeting EGFR may be appropriate
Primary small cell lung cancer, myeloma, lymphoma, leukemia, or other histologies not optimally treated with SRS
Pathologically proven diagnosis of a non-hematopoietic malignancy other than small cell lung cancer and germ cell malignancy within 5 years of registration; patients with metastasis of unknown primary tumor are permitted
Platinum sensitive relapsed small cell lung cancer (module 1)
For subjects in cohort 2 (small cell malignancies of non-pulmonary origin), confirmation of no brain metastases via imaging
Histologic diagnosis of solid malignant tumor including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors
INCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Patients with non-small cell lung cancer that is metastatic or inoperable and who have been treated with at least one line of prior therapy or declined conventional therapy
Pathologically confirmed non-small lung cancer
Recurrent or progressive advanced stage non-small cell lung cancer (no small cell component); NOTE: pathology reports documenting the diagnosis of NSCLC are required to be reviewed to confirm outside diagnosis
Biopsy-proven non-hematopoietic malignancy, except for small cell lung cancer, germ cell cancer, or unknown primary tumor
Newly diagnosed, histologically proven (or strongly suspected, see below) T1-T2aN0M0 (Stage IA-IB) non-small cell lung cancer (NSCLC), with maximum tumor diameter =< 5 cm under consideration for stereotactic ablative body radiotherapy (SABR) as definitive primary treatment
Prior use of platinum or paclitaxel for stage IV non-small cell lung cancer (NSCLC) or concurrent use of other anticancer approved or investigational agents
Patients with any component of small cell lung carcinoma
Histological/cytological diagnosis of non-small cell lung cancer (NSCLC). Squamous cell (epidermoid), adenocarcinoma, bronchoalveolar carcinoma and large cell anaplastic lung carcinoma histologies are eligible. Mixed histologies of NSCLC (i.e., adenosquamous) are eligible. Mixed NSCLC/small cell lung carcinoma (SCLC), and variant large and small cell lung cancer are NOT eligible for this study.
Pathologically confirmed non-small lung cancer
Non-small cell lung cancer of squamous histology
Advanced stage non-small cell lung cancer (NSCLC)
Histologic or cytologic diagnosis of adenocarcinoma non-small cell lung cancer
Stage IV non-small cell lung cancer or recurrent disease which cannot be approached with curative intent
Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung. according to WHO Classification of Tumours (WHO Classification of Tumours of the Lung, Pleura, Thymus and Heart. WHO/IARC Classification of Tumours, 4th Edition, Volume 7). Patients with large-cell neuroendocrine carcinomas are not eligible.
A combination of small cell and non-small cell lung cancer, pulmonary carcinoid tumour or large-cell neuroendocrine carcinoma (LCNEC).
Phase II: extensive stage small cell lung cancer with progression or recurrence after exactly one platinum-containing regimen. Patients who progressed during or within one month of completing platinum-based chemotherapy will be excluded. Patients who received primary curative chemoradiation therapy for limited disease, but who recur within the primary tumor site, previously radiated field or with distant metastases are also allowed to participate. Patients who have clinical evidence of recurrent small cell lung cancer do not require a confirmatory biopsy to be eligible for this trial. Prior irinotecan is not allowed.
Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
Any primary is eligible with exception of small cell lung cancer, lymphoma, and germ cell histologies
Small cell lung cancer, lymphoma, and germ cell histologies
Histologic or cytologic confirmation of lung cancer (squamous, ras-mutated adenocarcinoma or small cell lung cancer)
Pathologically proven diagnosis of unresected stage II-IIIB, or recurrent after surgical resection or stereotactic body radiation therapy (SBRT) non-small cell lung cancer
Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue
Diagnosis of non-small cell lung cancer.
Patients with small cell lung cancer and lymphoma are ineligible
Pathologically proven diagnosis of small cell lung cancer (SCLC)
Histologically confirmed diagnosis of one of the following cancers: melanoma (including mucosal and/or ocular), bladder/urothelial, non-small cell lung cancer, pancreatic adenocarcinoma, breast, colorectal, gastric, esophageal, renal cell, hepatic, ovarian, head and neck, and cholangiocarcinoma
Part 1: advanced stage solid tumors; Part 2: non-small cell lung cancer (NSCLC), pancreatic cancer and cutaneous melanoma
Confirmed locally advanced or metastatic non-small cell lung cancer that is unresectable
For the expansion cohort of non-small cell lung cancer (NSCLC) patients previously treated with and having progressed on immunotherapy patients must have no standard of care option available or have contraindications to such treatment (including those who decline such treatment)
Recurrent non-small cell lung cancer
Histological or cytological confirmed squamous or non-squamous non-small cell lung cancer.
Patients with measurable inoperable, histologically confirmed non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), esophageal carcinoma, thymic epithelial neoplasms, germ cell tumors, malignant pleural mesotheliomas or chest wall sarcomas, as well as patients with gastric, colorectal, pancreas or renal cancers, germ cell tumors and sarcomas metastatic to thorax are eligible
Radiosensitive or non-solid (eg. small cell lung carcinomas, germ cell tumors, leukemias, or lymphomas) or unknown tumor histologies
Histologic confirmation of non small cell lung cancer or other solid primary tumor metastatic to lungs
Medically inoperable stage I or II non small cell lung cancer with negative lymph nodes or metastatic cancer to lung with less than or equal to 3 lesions
Pathologically (histologically or cytologically) proven diagnosis of stage IIIA or IIIB non-small cell lung cancer within 84 days of registration; eligible histologies include adenocarcinoma, adenosquamous, large cell carcinoma, squamous carcinoma, non-lobar and non-diffuse bronchoalveolar cell carcinoma or non-small cell lung cancer not otherwise specified [NOS])
Patients with mixed small cell and non-small cell histologies
Radiosensitive primary tumor such as small cell lung cancer, germ cell tumors, lymphoma, leukemia, or multiple myeloma
Patients with any component of small cell lung carcinoma are excluded
Radiosensitive (eg. small cell lung carcinomas, germ cell tumors, leukemias, or lymphomas) or unknown tumor histologies
Histologic proof of non-small cell histology (adenocarcinoma, adenosquamous, large cell carcinoma, squamous carcinoma, non-lobar and non-diffuse bronchoalveolar cell carcinoma or non-small cell lung cancer not otherwise specified [NOS]) within 12 weeks of registration; note: mixed small cell and non-small cell histologies are not eligible for this study
Histologically confirmed small-cell lung cancer (SCLC) with documented disease progression after at least 2 prior systemic regimens, including at least one platinum-based regimen
Diagnosis of non-small cell lung cancer
Diagnosed with stage IV Non-Small Cell Lung Cancer
Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous concurrent chemoradiation with no further curative options.
Small Cell Lung Cancer
Non-small Cell Lung Cancer (NSCLC):
Patients with a histologically confirmed diagnosis of non-small cell lung cancer (NSCLC), including neuroendocrine tumors or small cell lung cancer (SCLC) who are being evaluated for palliative WBRT (with or without neurosurgical resection or stereotactic radiosurgery [SRS]) for radiologically or histologically diagnosed brain metastases presumed to be from the lung cancer are eligible for this Phase I study; group 2 will only include NSCLC patients
Histologically or cytologically confirmed carcinoma (prostate cancer, renal cell carcinoma, head and neck cancer, triple-negative breast cancer, bladder cancer, non-small cell lung cancer) or melanoma that overexpresses B7-H3.
Advanced non-small cell lung cancer
Histologically or cytologically documented non-small cell lung cancer (NSCLC), including squamous cell carcinoma, adenocarcinoma (including bronchioloalveolar carcinoma), and large cell anaplastic carcinoma (including giant and clear cell carcinomas) and poorly differentiated (not otherwise specified, NOS) non-small cell lung cancer; totally resected tumors are excluded\r\n* Patients must be M0;\r\n* Patients with T1 or T2 disease with N2 or T3N1-2 disease (stage IIIA) are eligible\r\n* Patients with T4 with any N or any T with N3 disease are eligible (stage IIIB)\r\n* Measurable disease is required
non-small-cell adenocarcinoma of the lung
Diagnosis of melanoma or other non-epithelial based malignancy such as sarcoma, neuroendocrine tumor, small cell lung cancer
Small-cell lung cancer (SCLC) defined as a histologically confirmed diagnosis of SCLC and must have received at least 1 chemotherapy-containing regimen for advanced disease (recurrent or metastatic).
Small cell cancer not lung in origin
Any ongoing toxicity ? Grade 2 attributable to prior Non-Small-Cell Lung Cancer (NSCLC) treatment
For all Parts: The participant must have stage IV non-small cell lung cancer (NSCLC).
Have mixed small cell and non-small cell histologic features.
Histologic confirmation of metastatic non-small cell lung cancer (NSCLC) and confirmed ALK rearrangement.
Unresectable recurrent or metastatic head and neck cancer (HNC) (non-squamous cell cancer allowed), renal cell cancer (RCC) (non-clear cell types allowed), melanoma and lung cancer and candidates for RT
Non-small cell lung adenocarcinoma
Pathologic evidence of chemo-resistant Small Cell Lung cancer (relapse <90 days after 1st line), chemo-sensitive Small Cell Lung Cancer (relapse >90 days after first line), locally advanced metastatic neuroendocrine tumor of gastro-entero, pancreatic, pulmonary (other than Small Cell Lung) or thymic origin, or advanced renal cell carcinoma for which everolimus is indicated.
Non-small cell lung cancer
Mixed small cell and non-small cell lung cancer histology.
Must have received or been previously offered standard first-line chemotherapy for advanced non-small cell lung cancer
Group 1: Patients with BRAF mutated cancer, except those with colorectal or non-small cell lung cancers
Group 6: Patients with BRAF mutated non-small cell lung cancer
Histological diagnosis of non-small cell lung cancer (NSCLC). Squamous cell (epidermoid), adenocarcinoma, bronchoalveolar carcinoma, and large cell anaplastic lung carcinoma histologies are eligible as are mixed histologies of NSCLC (i.e., adenosquamous). Mixed NSCLC/small cell lung carcinoma (SCLC), and variant large and small cell lung cancer are not eligible.
Mixed small cell and non-small cell lung cancer histology
Histological confirmation of malignancy (non-small cell lung cancer, breast cancer [hormone refractory], prostate cancer [hormone refractory], lymphoma, renal cell carcinoma, myeloma) by either biopsy or cytology of the primary or metastatic lesion
Histologically or cytologically confirmed non-small cell lung cancer; mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; cytologic or histologic elements can be established on metastatic tumor aspirate or biopsy; sputum cytology alone is not sufficient
Pathologically confirmed diagnosis of cancer, including, but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and carcinoma of unknown primary
Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
Prior chemotherapy or treatment for metastatic non-small cell lung cancer
Patients with measurable brain metastasis not resulting from small cell lung cancer and germ cell malignancy
Part B: Non-small cell lung cancer of any subtype that is advanced and/or metastatic
Pathologic diagnosis of non-small cell lung cancer prior to enrollment
Advanced biopsy-proven metastatic non-small cell lung cancer
Patients must have histologically documented metastatic or unresectable non-small cell lung cancer, head and neck cancer, urothelial transitional cell carcinoma, or breast cancer whose disease has progressed after at least one line of standard therapy
The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma
Participants in the Dose Escalation portion must have one of the following advanced or recurrent malignancies: gastrointestinal (colorectal or gastric); ovarian; melanoma; non-small cell lung adenocarcinoma; or bladder.
Diagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung or NSCLC NOS
Prior systemic anti-cancer therapy for small cell lung cancer
The participant has a solid tumor. Parts 2 and 3 are limited to participants with non-small cell lung cancer. Part 4 is limited to participants with small cell lung, head and neck, pancreatic, colorectal, and cervical cancers
Patients with CNS refractory small cell lung cancer having received standard recommended dosing for either of the two therapies:\r\n* Whole brain radiation therapy (WBRT)\r\n* Prophylactic cranial irradiation (PCI)
Individuals with KRAS-mutated metastatic or recurrent non-small cell lung cancer
Less than or equal to 3 weeks since receiving treatment with biologic, small molecule, chemotherapy or other agent for non-small cell lung cancer and 28 days since any prior immunotherapy (such as nivolumab)
NSCLC (Non-small-cell lung cancer): Patients with NSCLC and known KRAS status after platinum based chemotherapy.
Participants must have known HIV infection and histologically confirmed non-small cell lung cancer that is metastatic or unresectable; patients will be eligible regardless of tumor EGFR mutation status
Molecular characterization of non-squamous non-small cell lung cancer will be recommended prior to enrollment per standard of care/institutional guidelines; consistent with current National Comprehensive Cancer Network (NCCN) guidelines and the recent Food and Drug Administration (FDA)-approval indication of erlotinib for first-line treatment of advanced non-small cell lung cancer in persons with tumor EGFR mutations, participants who have known EGFR sensitizing mutations in tumors will be permitted to enter the study and receive erlotinib as initial monotherapy; for participants who have received one or more prior lines of chemotherapy, molecular characterization of tumors is required whenever possible with an understanding that inability to obtain sufficient tissue specimen for characterization will not preclude enrollment into the study
Histologic or cytologic confirmed locally advanced or metastatic small cell lung cancer, ovarian cancer, or cervical cancer (Part 1); small cell lung cancer and ovarian cancer (Part 2)
Patients with ovarian and small cell lung cancer must have failed initial therapy
Pathologically (histologically or cytologically) proven diagnosis of a non-hematopoietic malignancy other than small cell lung cancer and germ cell malignancy within 5 years of registration; if the original histologic proof of\r\nmalignancy is greater than 5 years, then pathological confirmation is required (e.g. from extra- or intra-cranial disease)
Patients with measurable brain metastasis(es) resulting from small cell lung cancer and/or germ cell malignancy
DOSE ESCALATION COHORT ONLY: Adult patients with histologic documentation of an advanced solid tumor for whom gemcitabine and carboplatin would be appropriate first line therapy, including but not limited to urothelial cancer, non-small cell lung cancer, pancreatic and ovarian carcinoma
Patients must have pathologically confirmed non-small cell lung cancer, including squamous, non-squamous, mixed histology, or large cell
In patients with non-squamous non-small cell lung cancer, investigators must be able to produce source documentation of the EGFR mutation status or ALK translocation status.
Non-small cell lung cancer metastatic to the pleura that extends outside of the pleura requiring immediate therapy
Histologically or cytologically documented, advanced, mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas
Part B4: Non-small cell lung cancer (squamous or non-squamous)
For Part B4 (non-small cell lung cancer) only:
Non-small cell lung cancer
Small cell lung cancer
Patients must have histological or cytological confirmed primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous, or unspecified); disease must be stage IV non-small cell lung cancer (NSCLC); disease may be either newly diagnosed or recurrent after previous surgery and/or irradiation; primary or metastatic site for biopsy is allowed
Pathologically confirmed: Non-small cell lung cancer (NSCLC, adenocarcinoma or squamous-cell carcinoma), Breast Cancer (HER2 positive or triple negative), Pancreatic Cancer (adenocarcinoma)
Histologically confirmed non-small cell lung cancer (NSCLC), who are deemed to be surgical candidates by standard criteria; patients with all types of NSCLC (e.g., adenocarcinoma, squamous cell carcinoma) will be allowed to enroll
6 weeks from surgery for stage 1 or 2 Non Small Cell Lung Cancer
Patients must understand the nature of the study and be willing to sign an informed consent that complies with the investigator/DEKK-TEC policies and approved by the Human Investigation Review Committee. Patients must have CNS involvement - from a malignancy. Lung cancer may be either small cell or non-small cell.
Diagnosis of stage IV non-small cell lung cancer, or stages II-III NSCLC that cannot be treated curatively with standard techniques
Non-small cell lung cancer (NSCLC) that is either EGFR or ALK mutated
Additionally, for patients who are considered for enrollment into the indication specific expansion cohorts in Stage 2, the current cancer must be either KRAS-mutant colorectal cancer (CRC) or KRAS-mutant non-small cell lung cancer (NSCLC)
Histologic or cytologic confirmation of non-small cell lung cancer (NSCLC)
Histologic or cytologic confirmed diagnosis of small cell lung cancer, either limited or extensive disease at initial presentation is allowed
Pathologic evidence of Small Cell Lung Cancer, or Non-Small Cell Lung Cancer.
Locally advanced or metastatic non-small cell lung cancer (stage IIIB or IV by AJCC 7th)
Subjects in the Phase 2 portion must have squamous cell Non-Small Cell Lung Cancer (NSCLC)
Must have Non-small Cell Lung Cancer with ALK+ mutation or other mutations or rearrangements potentially sensitive to crizotinib
Histologically confirmed non-small cell lung cancer with < 50% squamous-cell non-small cell lung cancer or colorectal cancer for which no potentially curative treatment options are available
The subject has a pathologic diagnosis of non-small cell lung carcinoma that is metastatic or unresectable
A minimum of 4 Squamous Non-Small Cell Lung Cancer (Sq-NSCLC)
Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
Radiosensitive or non-solid (eg. small cell lung carcinomas, germ cell tumors, leukemias, or lymphomas) or unknown tumor histologies
Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
Subjects with squamous non-small cell lung cancer and triple-negative breast cancer or other solid tumor types for which Notch activation has been demonstrated (such as pancreatic, ovarian and melanoma) during dose expansion
The participant's tumor fully or partially contains Small Cell Lung Cancer (SCLC).
Tumor wholly or partially contains small cell lung cancer
Histologically confirmed non-small cell lung cancer (NSCLC) or metastasis from another known or unknown primary by biopsy, or recurrent tumors in the setting of prior RFA/microwave or cryotherapy; eligible histological subtypes include: squamous cell carcinoma, adenocarcinoma, large cell neuroendocrine, and non-small cell carcinoma not otherwise specified
Patients that have a probable diagnosis of non-small cell lung cancer, of any stage, with obstructive or hemorrhagic endobronchial disease will be considered for enrollment
Centrally located non-small cell lung cancers and squamous cell lung cancers
Any advanced solid malignancy will be eligible, with a strong preference for tumors that are known to commonly harbor defects in homologous recombination repair including triple-negative breast cancer, high-grade serous ovarian cancer, non-small cell lung cancer, small cell lung cancer, mesothelioma castration-resistant prostate cancer, pancreatic adenocarcinoma, gastric cancer and head & neck squamous cell cancer
Biopsy proven non-small cell lung cancer
For dose expansion cohort, patients must have histologic or cytologic confirmed non-small cell lung cancer that are not curable
PATIENT: Diagnosed with advanced non-small cell lung carcinoma (NSCLC) being treated with non-curative intent, and informed of advanced disease within the prior eight weeks
Diagnosis of stages II-IV non-small cell lung cancer (NSCLC)
A diagnosis of either non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), or mesothelioma, not being treated with a curative intent
Patient has stage 3B or 4 non-small cell lung cancer (NSLC) or extensive stage small cell lung cancer (SCLC) and is within one month of treatment initiation
Pathologically proven solid tumor malignancy (except for small cell lung cancer [SCLC], germ cell tumor)
Diagnosed with advanced non-small cell lung cancer (NSCLC), small cell lung cancer, or mesothelioma, being treated with non-curative intent, and informed of advanced disease within the prior eight weeks
PATIENTS ONLY: Diagnosed with stage IV non-small cell lung cancer (NSCLC)
Patients with a histology of lymphoma, myeloma and small cell lung cancer histologies
Diagnosed with advanced non-small cell lung cancer (NSCLC), small cell lung cancer, or mesothelioma, being treated with non-curative intent, and informed of advanced disease within the prior eight weeks
PATIENT: Confirmed incurable lung cancer (non-small cell lung cancer [NSCLC], small cell lung cancer, or mesothelioma) or non-colorectal gastrointestinal (GI) cancer (esophageal, gastric, hepatic, biliary, or pancreatic or GI unknown primary) not being treated with curative intent
Patient is at least 3 weeks post-diagnosis of stage III or IV non-small cell or extensive small cell lung cancer and has received care at the Indiana University Simon Cancer Center or another Indiana University Health hospital or clinic
Confirmed metastatic lung cancer (non-small cell lung cancer [NSCLC], small cell lung cancer [SCLC], and mesothelioma [meso]) or non-colorectal gastrointestinal (GI) cancer (esophageal, gastric and hepatobiliary) not being treated with curative intent
Patients with measurable brain metastasis(es) resulting from small cell lung cancer and/or germ cell malignancy
Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer
Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer
Participants should preferably have histologically confirmed non-small cell lung cancer, but patients with a clinical and radiographic diagnosis of non-small cell lung cancer who are candidates for stereotactic body radiation therapy may also be eligible
Patients with early non-small cell lung carcinoma, or clinically-diagnosed early stage lung cancer, or pulmonary metastases
Subject has histologic or cytologic confirmation of lung cancer (non-small cell lung cancer [NSCLC] or small cell) and has been recommended thoracic radiotherapy as part of standard of care management
Patients receiving once daily fractionated intrathoracic radiation therapy for:\r\n* Stage IIA-IIIB non-small cell lung cancer\r\n* Limited stage small cell lung cancer\r\n* Stage I-III esophageal cancer (neoadjuvant or definitive)\r\n** For esophageal patients, accrual will be limited to patients that are NOT receiving trastuzumab
Patients with small cell lung cancer receiving twice daily (b.i.d.) radiation
Confirmed diagnosis of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)
Biopsy proven non-small cell lung cancer
Primary or locally recurrent stage I-IIA non-small cell lung cancer (NSCLC): T1-T2 N0 M0; tumor must be large enough to be above the detection threshold of PET imaging as determined by study investigators
Advanced small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC) of lung progressed after at least 1 line of anticancer chemotherapy
Patients must either have histologic or pathologically confirmed non-small cell lung cancer (NSCLC) or suspicious nodules/lesions which are going to be surgically resected before they are pathologically confirmed
A primary histopathological and/or cytopathological diagnosis of small cell lung cancer (SCLC)
Patient must have proven or suspected non-small cell lung cancer (NSCLC) (squamous cell, adenocarcinoma, or large cell) and be clinical stage I or II, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer (T1-3 N0, T1-2 N1)
All patients with early stage (stage I-III) non-small cell lung cancer, adenocarcinoma histology
Cancer Registry cases for diseases other than colon or rectal adenocarcinoma and non-small cell lung cancer (squamous or adenocarcinoma histology)
Diagnostic of small cell lung cancer or carcinoid tumors
Non-small cell lung cancer (NSCLC).
Part 2: Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer.
Part 2: Subjects with advanced or metastatic adenocarcinoma of endometrium, melanoma, non-small cell lung cancer, and renal cell carcinoma