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| Overall Recruitment Status: Enrollment not started |
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| Official Title |
| A RANDOMIZED, OPEN-LABEL PHASE 2/3 STUDY COMPARING COBOLIMAB + DOSTARLIMAB + DOCETAXEL TO DOSTARLIMAB + DOCETAXEL TO DOCETAXEL ALONE IN PARTICIPANTS WITH ADVANCED NON-SMALL CELL LUNG CANCER WHO HAVE PROGRESSED ON PRIOR ANTI-PD-(L)1 THERAPY AND CHEMOTHERAPY (COSTAR LUNG) |
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| Region |
Sponsors |
| Hawaii |
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| Acronym |
KP IRB No. |
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13428 |
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| Study Type |
Phase |
| Clinical Trial |
Phase III |
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| Study Population Description |
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| Purpose |
| This is a multi-center, parallel group treatment, Phase 2 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced Non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy. |
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| Detailed Description |
| Overall survival (OS) in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving docetaxel alone [ Time Frame: Up to 44 months ]
OS is defined as survival from the date of randomization to the date of death by any cause
OS in participants receiving dostarlimab + docetaxel relative to participants receiving docetaxel alone [ Time Frame: Up to 44 months ]
OS is defined as survival from the date of randomization to the date of death by any cause |
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| Gender |
Age Limit |
| Male & Female |
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- Participant has histologically or cytologically proven advanced or metastatic NSCLC and only squamous or non-squamous 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 an anti-PD-(L)1 antibody.
Participant has measurable disease.
Participant has documented radiographic disease progression on prior platinum based chemotherapy and on or after prior anti-PD-(L)1 therapy.
Participant agrees to submit an archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen that was collected on or after diagnosis of metastatic disease. If archival tissue is not available, the participant must undergo biopsy prior to study entry.
Participant has an ECOG performance status score of 0 or 1.
Participant has a life expectancy of at least 3 months.
Participant has adequate Baseline organ function.
Participant has recovered from any prior treatment related toxicities.
Participant agrees to use contraception.
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- Treated with an anti-PD-1, anti-PD-L1, or anti-PD-L2
agent that resulted in permanent discontinuation due to an AE.
Treated with an anti-TIM-3 or anti-CTLA-4 agent or
docetaxel.
Has a documented sensitizing EGFR, ALK, or ROS-1 mutation.
had radiological or clinical disease progression (ie, worsening performance.
status, clinical symptoms, and laboratory data) =8 weeks after initiation of prior anti-PD-1 or anti-PD-L1 antibody.
Has received radiation to the lung that is >30 Gy within 6 months prior to the first dose of study treatment.
Has completed palliative radiotherapy within 7 days prior to the first dose of study treatment.
Has a corrected QT interval (QTc) >450 msec (or QTc >480 msec for
participants with bundle branch block).
has had major surgery within 3 weeks prior to the first dose of study treatment or has not adequately recovered from any AEs (Grade =1) and/or complications from any major surgery.
See Clinical trials.gov for comprehensive list of exclusion criteria.
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