Health Condition 1: - Health Condition 2: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Arm A: Adagrasib + Pembrolizumab + Pemetrexed + Cisplatin/Carboplatin: Approximately 16 cycles treatment (each cycle is of 3 weeks). Following drug will be administered:
i) Adagrasib 40
Sponsors
Mirati Therapeutics Inc, a Bristol Myers Squibb Company
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC 2. Locally advanced or metastatic disease 3. Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion 4. No prior systemic anti-cancer therapy given for advanced or metastatic disease 5. Not a candidate for definitive therapy (eg chemoradiation or complete surgical resection) 6. Evidence of KRAS G12C mutation via tumor tissue and or ctDNA documented by Sponsor-approved laboratory testing 7. Any PD L1 expression (0 to 100 percentage ) as determined by VENTANA PD-L1 (SP263) assay, Agilent PD-L1 IHC 22C3 pharmDx or Agilent PD-L1 IHC 28-8 pharmDx. If despite best efforts a quantifiable result is not possible non-evaluable or non-quantifiable results may be acceptable upon Medical Monitor (or designee) approval for a maximum of 10 percentage of total participants. 8. Participants with brain metastases are eligible for enrollment including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be less than or equal to 20 mm in diameter.
Exclusion criteria
Exclusion criteria: 1.Participants with an active known prior documented or suspected autoimmune or inflammatory disease 2.Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment 3.Inadequate bone marrow function 4.Inadequate liver function 5.Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry 6.Treatment targeting KRAS G12C mutation (eg sotorasib adagrasib) in any setting 7.Certain significant ECG abnormalities 8.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival per RECIST v1.1 according to Blinded Independent Central Review (BICR)Timepoint: 1) Body scans Q6W until 1.5 years, then Q12W until BICR-confirmed progressive disease, even if the participant has discontinued study treatment. 2) Brain imaging Q6W (if baseline brain metastases) or Q12W (if no baseline brain metastases) until 1.5 years, then Q12W. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Overall Response & Duration of Response per RECIST v1.1 according to BICR & progression free survival according to investigator. 2) Treatment-related & all-cause AEs/SAEs, AEs leading to dose modifications, & fatal AEs 3) Patient related outcome assessments: NSCLC-SAQ & EORTC QLQ-C30Timepoint: 1) Patient survival follow up to 7 years, Death, withdrawal of consent, loss to follow up or End of study whichever occurs first 2) Until disease progression or participants who discontinue treatment due to reasons other than disease progression. | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Croatia, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Republic of Korea, Romania, Saudi Arabia, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States of America
Contacts
Public ContactShilpi Sinha
Bristol Myers Squibb India Pvt. Ltd.
Outcome results
None listed