Willing to undergo core needle or incisional biopsy to obtain fresh tumor tissue specimens
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at least 4 unstained slides, with an associated pathology report, for central testing of tumor PD-L1 expression a) Tumor tissue should be of good quality based on total and viable tumor content. Fine needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable. For core-needle biopsy specimens, at least three cores should be submitted for evaluation. b) Patients who do not have tissue specimens meeting eligibility requirements may undergo a biopsy during the screening period. Acceptable samples include core needle biopsies for deep tumor tissue (minimum of three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions. c) Tumor tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not acceptable
Confirmed availability of representative archival tumor specimens in paraffin blocks (preferred) or >= 10 unstained slides, with an associated pathology report\r\n* Acceptable samples include core needle biopsies for deep tumor tissue or excisional, incisional, or punch biopsies for cutaneous, subcutaneous, or mucosal lesions\r\n* Tumor tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not acceptable\r\n* A subject with insufficient or unavailable archival tissue may be eligible, upon discussion with the principal investigator, if the subject is willing to consent to undergo a pretreatment core, punch, or excisional/incisional biopsy sample collection of the tumor
Tissue Parameters: a. Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at least 4 unstained slides, with an associated pathology report, for testing of tumor PD-L1 expression (tumor tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not acceptable). b. Tumor tissue should be of good quality based on total and viable tumor content. Fine needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable. For core-needle biopsy specimens, at least three cores should be submitted for evaluation. c. Patients who do not have tissue specimens meeting eligibility requirements must be willing to undergo a biopsy during the screening period
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at least 5 unstained slides, with an associated pathology report, for central testing of tumor PD-L1 expression \r\n* Tumor tissue should be of good quality based on total and viable tumor content; fine needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable; for core-needle biopsy specimens, at least three cores should be submitted for evaluation\r\n* Patients who do not have tissue specimens meeting eligibility requirements may undergo a biopsy during the screening period; acceptable samples include core needle biopsies for deep tumor tissue (minimum of three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions\r\n* Tumor tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not acceptable
Willingness to undergo a biopsy ? 6 weeks of the start of study treatment to obtain formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at least 15 unstained slides, with an associated pathology report, for central testing of tumor PD-L1 expression\r\n• Archival tissue is acceptable if obtained within the protocol specified period and if there is no intervening therapy between the tumor biopsy and the initiation of atezolizumab; tumor tissue should be of good quality based on total and viable tumor content; fine-needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable; for core-needle biopsy specimens, at least three cores should be submitted for evaluation\r\n* Patients who do not have tissue specimens meeting eligibility requirements will be required to undergo a biopsy during the screening period; acceptable samples include core-needle biopsies for deep tumor tissue (minimum of three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions\r\n* Tumor tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not acceptable
Submission of formalin-fixed, paraffin-embedded (FFPE) archival tumor specimens from the previous 18 months, if available; if not available, a fresh tumor biopsy prior to treatment initiation is MANDATORY unless determined medically unsafe or not feasible by the site investigator\r\n* The archival specimen must contain adequate viable tumor tissue\r\n* Specimens may consist of a tissue block (preferred and should contain the highest grade of tumor) or a recommended minimum of 20 unstained serial sections; fine-needle aspiration, brushings, cell pellet from pleural effusion, bone marrow aspirate/biopsy are not acceptable\r\n* Distant metastases specimens are preferred but if not available primary nephrectomy specimens are acceptable
Representative tumor tissue specimens (paraffin block preferred)
Patients must have adequate tumor tissue available for PD-L1 testing; adequate tumor tissue is defined as:\r\n* For core-needle biopsy specimens, at least three cores should be submitted for evaluation if feasible; acceptable samples include core-needle biopsies for deep tumor tissue (minimum of three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions; samples collected from fine-needle aspiration, brushing, cell pellet from pleural effusion, bone metastases without a soft tissue component, and lavage are not acceptable\r\n* For pre-treatment archival tissue, representative urothelial carcinoma formalin-fixed paraffin-embedded (FFPE) tumor specimens (tumor blocks or 30 unstained slides) must be provided; patients with < 30 slides may be enrolled after discussion with the MSK principal investigator\r\n* Primary or metastatic specimens (with the exception of bone because it is not evaluable for PD-L1 expression) may be submitted
Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, requested at any time prior to study entry; only tissue from core needle, punch, or excisional biopsy sample collection will be accepted; fine-needle aspiration, brushing, and lavage samples are not acceptable; for all biopsy types, submitted blocks should have sufficient tissue to generate at least 15 sections, and tissue for which the pathology report specifies that the overall tumor content is low (e.g., “sparse” or “scant”) is not acceptable; tissue from separate time points (such as time of initial diagnosis and time of metastatic diagnosis) or from the multiple metastatic tumors may also be collected for a given patient, on the basis of availability
If archival tissue is either insufficient or unavailable, the patient may still be eligible if the patient can provide at least five unstained, serial slides or is willing to consent to and undergo a pre-treatment core or excisional biopsy sample collection of the tumor; fine-needle aspiration, brushing, and lavage samples are not acceptable
For participants who will undergo serial biopsy in dose-escalation cohort, baseline tumor tissue samples should be of core needle biopsies for deep tumor tissue or organs or excisional or punch biopsies for cutaneous or subcutaneous lesions (>/=5 millimeter [mm] in diameter amenable to serial biopsy)
If an archived tumor block exists, then either the block or at least 4 unstained slides from the block should be submitted. Tumor tissue should be of good quality based on total and viable tumor content, i.e. at least 50 viable tumor cells and intact tissue architecture. Fine needle aspiration, brushing,and lavage samples are not acceptable. If the block is tissue from a core-needle biopsy, then the block should contain tissue from at least three cores to be sufficient for evaluation.
Patients who do not have existing (archived) tissue specimens meeting eligibility requirements may undergo a biopsy during the screening period. Acceptable samples include core needle biopsies for deep tumor tissue (minimum of three cores) or excisional, or forceps biopsies for endobronchial or nodal lesions. The tissue should be fixed in formalin and embedded on site and sent as a block.
Archival tumor specimens must be submitted prior to enrollment; samples collected from fine-needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage are not acceptable; acceptable samples include core-needle biopsies for deep tumor tissue (minimum of three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions; if archival tissue is being used, representative urothelial carcinoma formalin-fixed paraffin-embedded (FFPE) tumor specimens (tumor blocks or 30 unstained slides) must be provided; patients with < 30 slides may be enrolled after discussion with the principal investigator; primary or metastatic specimens may be submitted
Representative tumor specimens in paraffin blocks (preferred) or at least 10 unstained slides, with an associated pathology report, requested at any time prior to study entry; only tissue from core needle, punch, or excisional biopsy sample collection will be accepted; fine-needle aspiration, brushing, and lavage samples are not acceptable; for all biopsy types, submitted blocks should have sufficient tissue to generate at least 10 sections, and tissue for which the pathology report specifies that the overall tumor content is low (e.g., \sparse\ or \scant\) is not acceptable; if archival tissue is either insufficient or unavailable, the patient will need to consent to and undergo a pre treatment core or excisional biopsy sample collection of the tumor; fine needle aspiration, brushing, and lavage samples are not acceptable; the immediate unavailability of tissue blocks or unstained slides aside from the slides needed for diagnostic confirmation of lung cancer does not exclude patients from this trial; if the patient chooses to not undergo a repeat biopsy aside from biopsy for diagnostic purposes, the patient will still be eligible to enroll on 2014-0722; however, availability of core or excisional biopsy samples must be ascertained prior to enrollment
A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient
Representative tumor specimens in paraffin blocks (preferred) or at least 10 unstained slides, with an associated pathology report, requested at any time prior to study entry. Tissue from core needle, punch, or excisional biopsy sample collection is preferred but slides from fine needle aspiration, brushing, and lavage samples are acceptable.
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at least 10 unstained slides, with an associated pathology report, for central testing of tumor PD-L1 expression\r\n* Tumor tissue should be of good quality based on total and viable tumor content; fine-needle aspiration, brushing, cell pellet from pleural effusion, and lavage samples are not acceptable; for core-needle biopsy specimens, at least three cores should be submitted for evaluation\r\n* Patients who do not have tissue specimens meeting eligibility requirements may undergo a biopsy during the screening period; acceptable samples include core-needle biopsies for deep tumor tissue (minimum of three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions