Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants with Advanced NSCLC who Progressed on Prior Anti PD (L)1 Therapy and Chemotherapy (COSTAR LUNG)

You may be able to join if

• "Participant is ≥18 years old, is able to understand the study procedures, and agrees to participate in the study by providing written informed consent (as described in APPENDIX 5), which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Note: Participants in Korea are eligible if they are 19 years or older at the time consent is obtained."
• "Participant has histologically or cytologically proven advanced or metastatic NSCLC, and only squamous or nonsquamous cell carcinoma."
• "Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum-based (e.g., cisplatin, carboplatin) doublet chemotherapy regimen and an anti-PD-1 or anti-PD-L1 antibody (no other biologic alone or in combination; novel combinations are not allowed). Participants previously treated with targeted therapies, including angiogenesis inhibitors (e.g., bevacizumab, ramucirumab, lenvatinib), are not eligible. Two components of treatment must have been received in the same line or as separate lines of therapy as follows: • A maximum of 1 line of therapy containing a platinum-based chemotherapy in the metastatic setting and • A maximum of 1 line of therapy containing an anti-PD-1 or anti-PD-L1 antibody Note the following: − An anti-PD-1 or anti-PD-L1 antibody received during a previous clinical study meets this requirement if the antibody has been approved for an indication in at least 1 country. − Participants from the Phase 3 PACIFIC clinical study (NCT02125461) who received the experimental regimen (chemoradiotherapy followed by durvalumab) (Antonia, 2017) or participants who received a regimen similar to the PACIFIC regimen (chemoradiotherapy followed by an anti-PD-1 or anti-PD-L1 antibody) as part of standard of care and have relapsed within 1 year of the first dose of chemoradiotherapy fulfill the protocol requirement for platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 antibody therapy. These regimens are considered 1 line of therapy for stratification purposes. − The anti-PD-1 or anti-PD-L1 antibody can be administered with the platinum-based chemotherapy, and this is considered 1 line of therapy with both agents and no other lines are allowed. − The anti-PD-1 or anti-PD-L1 antibody may be counted as a prior treatment if the antibody is approved in at least 1 country for the treatment of cancer. − Participants who have completed 2 years of treatment with pembrolizumab or another anti-PD-1 or anti-PD-L1 antibody, discontinued from that therapy, experienced disease progression, and are then retreated with an anti-PD-1 or anti-PD-L1 antibody will be considered as having had 1 line of anti-PD-1 or anti-PD-L1 therapy. − Adjuvant or neoadjuvant systemic anticancer therapy will not count toward the 2 lines of therapy unless disease recurs during the first year following the start of adjuvant chemotherapy."
• "Participant has measurable disease, that is, presenting with at least 1 measurable lesion per RECIST v1.1 as determined by the local site Investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if disease progression has been demonstrated in such lesions and if there are other target lesions. If there is only 1 target lesion that was previously irradiated, the participant is not eligible. See APPENDIX 1 for the definition of a measurable lesion."
• "Participant has documented radiological disease progression on prior platinum-based chemotherapy and on prior anti-PD-1 or anti-PD-L1 therapy according to RECIST v1.1."
• "Participant agrees to submit an archival FFPE tumor tissue specimen that was collected on or after diagnosis of metastatic disease from location(s) not irradiated prior to biopsy. Both tissue block and freshly cut slides are acceptable. If archival tissue is not available, the participant must undergo biopsy prior to study entry. See the Study Reference Manual for further details. a. Participants are also encouraged, but not required, to have a fresh tumor tissue biopsy of a primary or metastatic tumor prior to dosing (samples will be used to enable biomarker analysis). For a full list of Inclusion criteria please refer to the Study Protocol Section 5.1 Inclusion Criteria pg57-61 "