Pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present prior to registration; this includes patients newly diagnosed with metastatic disease or those initially diagnosed and treated for stage I-III NSCLC who ultimately develop metastases.
Prior systemic therapy as part of concurrent treatment approach for previously diagnosed stage III NSCLC, adjuvant therapy for stage III NSCLC, as adjuvant therapy for previously resected NSCLC, or for other previous cancers is permitted.
Cutaneous metastasis of NSCLC.
For NSCLC:
Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
Mandatory provision of adequate archived stage IV NSCLC tissue samples or tissue samples other than stage IV NSCLC may be acceptable (optional for part C).
For patients with SCCHN or NSCLC, ongoing anticoagulant therapy
Has received prior systemic chemotherapy/other targeted or biological antineoplastic therapy treatment for their Stage IV metastatic NSCLC
No prior systemic NSCLC treatment.
Has not received prior systemic treatment for metastatic NSCLC.
Histologically or cytologically proven diagnosis of NSCLC or SCLC; in cases where the histology and cytopathology results are consistent with a carcinoma but immunohistochemistry stains are indeterminate and unable to support the lungs as the most likely site of origin, the diagnosis of NSCLC or SCLC may be established in conjunction with the radiographic and clinical picture
Cohort B: metastatic NSCLC
Histopathologically confirmed diagnosis of metastatic NSCLC.
Confirmed diagnosis of Stage III or Stage IV NSCLC and have received ? line of prior systemic therapy in the locally advanced or metastatic setting
Histological or cytological diagnosis of advanced/metastatic solid tumor. Measurable disease by RECIST . with at least measurable lesion that has not been previously irradiated. Availability of tumor specimen taken within year prior to study entry, with no intervening systemic anti-cancer therapy. No prior PD-/PDL- therapy allowed. Combination A: Phase b, patients with NSCLC that have progressed on standard therapy or for which no standard therapy is available, and Phase , patients with NSCLC, melanoma, SCCHN, TNBC in any line of therapy, SCLC, st line NSCLC. st line NSCLC must demonstrate to express PD-L. Activating EGFR mutation, ALK, ROS translocation/rearrangements are not permitted. Combination B: Phase b, patients with advanced solid tumors (NSCLC, SCCHN, melanoma) that have progressed on standard therapy or for which no standard therapy is available, and Phase , patients with NSCLC, melanoma, or SCCHN. Up to lines of prior therapy in advanced/metastatic disease setting allowed. Activating EGFR mutation, ALK, ROS translocation/rearrangements are not permitted. Combination C: Ovarian cancer, SCCHN, NSCLC, gastric cancer, platinum resistant ovarian cancer. Up to lines of prior therapy in advanced/metastatic disease setting allowed. TGCT/PVNS that is either inoperable or requires extensive resection. Prior treatment with agents targeting CSF-/CSF-R not allowed. NSCLC activating EGFR mutation, ALK, ROS translocation/rearrangements are not permitted. Combination D: NSCLC, melanoma, SCCHN, bladder cancer. NSCLC activating EGFR mutation, ALK, ROS translocation/rearrangements are not permitted. Up to lines of prior therapy in advanced/metastatic disease setting allowed.
Any prior treatment for NSCLC
Have a histologic diagnosis of stage IV NSCLC
Has received prior chemotherapy for NSCLC with the exception of neoadjuvant or adjuvant platinum-based chemotherapy for NSCLC completed > months prior to enrollment
No prior chemotherapy or radiotherapy for NSCLC
Patients must have advanced or metastatic NSCLC
Prior therapy with microtubule destabilizing agents for NSCLC (i.e. vinorelbine)
Participants in Part D must have NSCLC of any subtype.
Group : KRAS mutant NSCLC (Part B)
Histologically confirmed stage IV NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or not otherwise specified) or recurrent NSCLC not amenable to curative therapy
Stage IV NSCLC, or recurrent NSCLC that is not potentially curable by radiotherapy or surgery whether or not they have received prior chemotherapy. There is no limit to the number of prior chemotherapy regimens received.
Stage IV pathologically proven NSCLC.
Previous systemic therapy for stage IV NSCLC, including chemotherapy, radiation therapy or non-cytotoxic investigational agents.
Has received prior systemic chemotherapy treatment for metastatic/recurrent NSCLC
Have stage IV, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with progressive disease after platinum containing chemotherapy (EGFR mutant, ALK, or ROS- rearranged NSCLC must have progressed on prior approved tyrosine kinase inhibitor [TKI]s)
Have metastatic melanoma or NSCLC, or locally advanced NSCLC not suitable for curative-intent local therapy
Participants with prior chemotherapy or radiotherapy (RT) for current NSCLC. Participants curatively treated for past early stage NSCLC greater than years ago may be included.
Radiographic evidence of recurrent NSCLC prior to afatinib treatment
Histologically confirmed locally advanced or stage IV NSCLC
Prior systemic therapy for metastatic or recurrent NSCLC.
Part B: NSCLC
Cohort C: Histologically confirmed metastatic solid tumor of epithelial origin, including both NSCLC and non-NSCLC, with radiographic evidence by MRI of at least one measurable brain lesion as defined by RANO criteria that requires corticosteroids for symptomatic control
Diagnosis of advanced or metastatic NSCLC. Group A must be ALK negative NSCLC and Group B must be ALK positive NSCLC
Confirmed diagnosis of stage IV NSCLC.
NSCLC
The participant has Stage IV NSCLC.
Part A: NSCLC Stage IV (any type)
Part B: NSCLC Stage IV (squamous and nonsquamous)
Part C: NSCLC Stage IV in Japanese participants (squamous and nonsquamous)
Bilirubin > x ULN that cannot be attributed to NSCLC metastasis
Treatment with more than one prior line of treatment for advanced NSCLC
Patients must have biopsy proven metastatic NSCLC (stage IV)
Patients with cutaneous metastasis of NSCLC
Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy
Patient meets the FDA-approved indication for Atezolizumab treatment in NSCLC.
Patients selected for this study will have clinical stage I or II NSCLC; subjects with evidence of enlarged N nodes by routine computed tomography (CT) scan imaging or those with clinical stage III or IV NSCLC are excluded
Patients with advanced stage NSCLC who are candidates for single or multi-agent first-line therapy
Histological diagnosis of NSCLC or MPM; pts must have clinical and/or pathological evidence of pleural spread or stage III/IV MPM
Prior treatment for NSCLC except for pleurodesis and/or standard frontline chemotherapy
Patients with histologically confirmed advanced NSCLC, SCLC and thymic malignancies for whom surgical resection or multimodality therapy with curative intent is not feasible; for patients with stage III NSCLC, who can be encompassed by a radiation port, definitive external radiation therapy (XRT) should have been performed first when possible
Has received prior treatment with chemotherapy or biologic therapy for stage IV NSCLC.
Malignancies other than non-squamous NSCLC successfully treated within years prior to randomization (with the exception of certain early-stage cancers)
No prior treatment for Stage IV squamous NSCLC
NSCLC that has progressed on prior treatment
Histologically documented recurrent or advanced (Stage IV) NSCLC
Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) prior to fiducials placement and subsequent SBRT; because fiducials will be placed exclusively by ENB, which can also be used for pathological diagnosis of malignancy, there will be two categories of eligibility:\r\n* Participants already carry a histological or cytological diagnosis of NSCLC and will undergo an ENB procedure solely for the placement of fiducial tumor markers; participants in this category need not be newly diagnosed; a participant who was previously histologically or cytologically diagnosed with NSCLC and now presents with a new tumor confirmed by imaging may be treated on this protocol without an additional biopsy; in this case, the prior pathological diagnosis will be used to establish a NCLC diagnosis for this protocol\r\n* Participants present with an indeterminate lung tumor and undergo ENB for both NSCLC diagnosis and fiducials placement; in this setting, the subject will sign informed consent prior to the ENB procedure and be enrolled only after intraoperative histological or cytological confirmation of NSCLC and placement of fiducial markers
Malignancy other than NSCLC within years prior to randomization and evidence of any other disease that contraindicates the use of an investigational or SOC drug
The participant is currently or has previously received chemotherapy for advanced (Stage IV) NSCLC.
Confirmed NSCLC
Patients with stage II IV non squamous cell NSCLC who received at least Gy of total planned thoracic radiation dose will be eligible; patients must have received at least one cycle of chemotherapy concurrently during the course of thoracic radiation; regimens allowed are platinum combinations with either etoposide or a taxane regardless of histology subtype; platinum with pemetrexed for patients with non-squamous NSCLC only; patients with oligometastatic stage IV cancer are eligible if they have received only one line of systemic therapy for their stage IV cancer prior to the concurrent chemoradiation phase
Diagnosis of NSCLC
Patient participants must have stage III, IV and/or recurrent NSCLC
Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
Subjects with stage IV NSCLC (not recurrent or re-staged).
Subject must have a suspected SCLC or NSCLC
No prior treatment for this diagnosis of NSCLC
Patients must have pathologically documented advanced NSCLC (stage IV or recurrent)
Patient must be eligible for definitive surgical therapy for primary NSCLC
On average, cares for at least AA patients with early stage NSCLC per year (based on the last years of cancer registry data)
Pathologically confirmed stage IV NSCLC (with any Eastern Cooperative Oncology Group [ECOG] performance status, and any NSCLC adenocarcinoma, squamous cell, etc.) with available imaging OR patients who do not yet have their staging completed, but in the judgment of the physician are likely to be stage IV;\r\n* Patients may be enrolled if the recruiter cannot reach the patient by the first office visit, preferably prior to starting therapy and no later than one month after starting therapy; (NCCN guidelines allow for a switch to targeted therapy from chemotherapy if testing comes back positive after starting chemotherapy)
Have a Stage IV diagnosis of of the following: Part A: NSCLC (Kirsten rat sarcoma mutant [KRAS mt], PD-L+); Part B: NSCLC (squamous histology); or Part C: metastatic breast cancer (HR+, HER-).
Part A: must be chemotherapy nave for metastatic NSCLC