Non-Small Cell Lung Cancer, NSCLC Clinical Trial
Official title:
A Platform Study of RAS(ON) Inhibitor Combinations in Patients With RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)
The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with each other. The first two subprotocols include the following: Subprotocol A: RMC-6291 + SOC Subprotocol B: RMC-6236 + SOC
Status | Recruiting |
Enrollment | 352 |
Est. completion date | December 2028 |
Est. primary completion date | June 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: All Patients (unless otherwise noted): - = 18 years of age - ECOG PS is 0 to 1 - Adequate organ function as outlined by the study - Received prior standard therapy appropriate for tumor type and stage - Must have pathologically documented, locally advanced or metastatic KRAS G12C-mutated solid tumor malignancy (not amenable to curative surgery) (Subprotocol A) - Must have pathologically documented, locally advanced or metastatic RAS-mutated NSCLC (Subprotocol B) Exclusion criteria: All Patients: - Primary central nervous system (CNS) tumors - Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs - Major surgery < 28 days of first dose - Active or history of interstitial lung disease (ILD) or pneumonitis requiring steroids Other inclusion/exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
United States | NEXT Oncology Virginia | Fairfax | Virginia |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | NEXT Oncology Dallas | Irving | Texas |
United States | Boca Raton Clinical Research Associates | Plantation | Florida |
United States | Clinical Research Alliance | Westbury | New York |
Lead Sponsor | Collaborator |
---|---|
Revolution Medicines, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events | Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs and vital signs | Up to 5 years | |
Primary | Dose limiting toxicities | Number of participants with dose limiting toxicities | 21 days | |
Secondary | Cmax | Maximum observed blood concentration of each drug per subprotocol | Up to 21 weeks | |
Secondary | Tmax | Time to reach maximum blood concentration of each drug per subprotocol | Up to 21 weeks | |
Secondary | AUC | Area under the concentration-time curve of each drug per subprotocol | Up to 21 weeks | |
Secondary | ORR | Overall Response Rate per RECIST v1.1 | Up to 5 years | |
Secondary | DOR | Duration of Response per RECIST v1.1 | Up to 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03523702 -
The Selective Personalized Radio-Immunotherapy for Locally Advanced NSCLC Trial.
|
Phase 2 |