ADAGRASIB for Non-small cell lung cancer | KRAS G12C-mutated non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Histologically or cytologically confirmed diagnosis of non-squamous NSCLC."}
• {"criterion_text":"- Locally advanced or metastatic disease."}
• {"criterion_text":"- Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion."}
• {"criterion_text":"- No prior systemic anti-cancer therapy given for advanced or metastatic disease."}
• {"criterion_text":"- Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection)"}
• {"criterion_text":"- 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 ≤ 20 mm in diameter."}

Exclusion criteria

• {"criterion_text":"- Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years prior to randomization.."}
• {"criterion_text":"- Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment."}
• {"criterion_text":"- Inadequate bone marrow function."}
• {"criterion_text":"- Inadequate liver function."}
• {"criterion_text":"- Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry."}
• {"criterion_text":"- Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting."}
• {"criterion_text":"- Certain significant ECG abnormalities."}
• {"criterion_text":"- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration."}
• {"criterion_text":"- Evidence of active infection requiring parenteral therapy in the 2 weeks prior to randomization."}

Primary endpoints

• {"endpoint_text":"- To compare PFS of adagrasib + pembrolizumab + chemotherapy to placebo + pembrolizumab + chemotherapy.","definition_or_measurement_approach":""}
• {"endpoint_text":"- To compare OS of adagrasib + pembrolizumab + chemotherapy to placebo + pembrolizumab + chemotherapy.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- PFS per RECIST v1.1 according to BICR.","definition_or_measurement_approach":"PFS assessed according to RECIST v1.1 as determined by Blinded Independent Central Review (BICR)."}

Primary sponsor

Full Name

Bristol-Myers Squibb Services Unlimited Company

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland

Contract research organisations

Name

Iqvia Holdings Inc.

Responsibilities

site payments

Name

Endpoint Clinical Inc.

Responsibilities

IVRS – treatment randomisation, Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment

Name

Medidata Solutions Inc.

Responsibilities

eClinical platform / data management (documented duties code 6)

Third parties

• {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"translation services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Routine clinical pathology testing, Clinical chemistry, Clinical haematology, Clinical microbiology, IHC Biomarker expression analysis (PD-L1), other APH","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"Speciality Biomarker Laboratory","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements,electronic study-related comunications to patients","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"Central Lab","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"plasma sample analysis related to PK","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Holdings Inc.","duties_or_roles":"site payments","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Massive Bio Inc.","duties_or_roles":"Patient Recruitment","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"plasma sample analysis related to PK","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Routine clinical pathology testing, Clinical chemistry, Clinical haematology, Clinical microbiology, Tumor blocks/slides storage,PGX spl, spl storage for vendors,IHC,Legacy LabCorp Central Lab","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"IVRS – treatment randomisation, Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment","organisation_type":"Pharmaceutical company"}
• {"country":"Japan","full_name":"Labcorp Development Japan K.K.","duties_or_roles":"Central Lab, Sample mgmt, Kit building, Storage and distribution of samples to other vendors","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Licensing and translation services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"IVRS - treatment randomisation, PRO/eCOA","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Illumina Inc.","duties_or_roles":"Plasma ctDNA analysis","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"Routine clinical pathology testing, Clinical chemistry, Clinical haematology, Clinical microbiology, Central Lab","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Proprietary clinical data management / eClinical services (document code 6)","organisation_type":"Non-Pharmaceutical company"}