Health Trials

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

ConditionNon-Small Cell Lung Cancer (NSCLC)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorAmgen

About this trial

The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing

No history of systemic anticancer therapy in metastatic/non-curable settings

Eastern Cooperative Oncology Group (ECOG) ≤ 1

Disqualifiers

Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology

Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy

Symptomatic (treated or untreated) brain metastases

Gastrointestinal (GI) tract disease causing the inability to take oral medication

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sotorasib

    Drug

    Oral administration

  • Pembrolizumab

    Drug

    Intravenous administration

Treatment groups

750 Participants
are divided into 2 treatment groups
Group A: Sotorasib combined with carboplatin and pemetrexedExperimental treatment 1 intervention
Group B: Pembrolizumab combined with carboplatin and pemetrexedActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free Survival (PFS)

PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR).

Time frame
Approximately 2.5 years
2

Overall Survival (OS)

OS is defined as the time from randomization until death due to any cause.

Time frame
Approximately 2.5 years

Secondary outcomes

1

Objective Response Rate (ORR)

Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1, per BICR.

Time frame
From Baseline up to end of study (EOS) (approximately 5.5 years)
2

Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score

Time frame
From Baseline to Week 12
3

Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale

Time frame
From Baseline to Week 12
4

Change in QLQ-LC13 Symptoms of Cough Subscale

Time frame
From Baseline to Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Source ClinicalTrials.gov
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