Amivantamab + Olomorasib for Non-Small Cell Lung Cancer
(KaRAnaSa Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment combination of two drugs, amivantamab and olomorasib, for individuals with non-small cell lung cancer (NSCLC) that has metastasized. The goal is to determine the optimal dose and assess how effectively these drugs can slow or halt the growth of tumors with a KRAS G12C mutation, a genetic change affecting cell growth. Suitable candidates for this trial have the KRAS G12C mutation, have experienced cancer progression after specific treatments, and possess at least one measurable tumor. As a Phase 1, Phase 2 trial, this research aims to understand the treatment's effects in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer research.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research is examining the safety and effectiveness of combining amivantamab and olomorasib for treating lung cancer with a specific mutation. Earlier studies have shown that these two drugs together generally result in manageable side effects. Specifically, olomorasib, when combined with pembrolizumab, showed promising results and manageable safety in patients with a similar type of lung cancer.
While these findings are encouraging, the current trial is still determining the optimal dose for the combination. Researchers are closely monitoring side effects to ensure the treatment's safety for participants. As this treatment undergoes early-phase trials, safety remains a key focus, though previous tests provide some confidence in its tolerability.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of amivantamab and olomorasib for non-small cell lung cancer (NSCLC) because it targets cancer cells in a novel way. Amivantamab is a bispecific antibody, which means it can bind to two different proteins on the cancer cell surface, potentially improving its ability to inhibit tumor growth. Olomorasib is a KRAS G12C inhibitor, specifically targeting a mutation commonly found in NSCLC, offering a more precise attack on cancer cells. Together, this combination could provide a more effective treatment option by simultaneously targeting multiple pathways that cancer cells use to grow and spread, which is a step beyond the current standard treatments like chemotherapy and targeted therapies that often focus on a single target.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?
Research has shown that combining olomorasib with pembrolizumab helps shrink tumors in 77% of patients with KRAS G12C-mutated metastatic non-small cell lung cancer (NSCLC). Although researchers have not yet tested amivantamab with olomorasib, amivantamab is approved for use with lazertinib to treat advanced NSCLC with a different mutation, demonstrating its potential effectiveness. This trial aims to determine if amivantamab and olomorasib can work together to slow or stop tumor growth in this specific lung cancer. Participants will receive the combination therapy to identify the optimal dose for this effect.14567
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
This trial is for adults with metastatic NSCLC that has a specific KRAS G12C mutation. They should be relatively healthy (ECOG status of 0 or 1), have at least one measurable tumor, and may have stable brain metastases. Participants must have tried platinum-based chemo and PD-L1 immunotherapy without success.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Combination Dose Selection
Participants receive amivantamab along with olomorasib to determine the RP2CD of the combination therapy until disease progression, significant toxicity, or another criterion for discontinuation is met.
Phase 2: Expansion
Participants receive amivantamab and olomorasib combination therapy at the RP2CD determined in Phase 1 until disease progression, significant toxicity, or another criterion for discontinuation is met.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Extension (optional)
Eligible participants may opt into continuation of treatment long-term for continued access to study treatments.
What Are the Treatments Tested in This Trial?
Interventions
- Amivantamab
- Olomorasib
Trial Overview
The study tests the combination of two drugs, Amivantamab and Olomorasib, to determine the best dose and effectiveness in slowing or stopping tumor growth in patients with a specific type of advanced lung cancer.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive amivantamab and olomorasib combination therapy at the RP2CD determined in Phase 1 until disease progression, significant toxicity, or until another criterion for discontinuation of study treatment is met. Eligible participants may have the option to transfer to LTE phase for continued access to study treatments.
Participants will receive amivantamab along with olomorasib to determine the RP2CD of the combination therapy until disease progression, significant toxicity, or until another criterion for discontinuation of study treatment is met. Eligible participants may have the option to transfer to a long-term extension (LTE) phase for continued access to study treatments.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Citations
NCT07227025 | A Study of Amivantamab and Olomorasib ...
The main purpose of this study is to find out the most suitable dose (recommended phase 2 combination dose [RP2CD]) of amivantamab and olomorasib ...
Olomorasib Combo Elicits Favorable Efficacy in NSCLC
Olomorasib with pembrolizumab in the first-line showed a 77% overall response rate in patients with KRAS G12C–mutated metastatic non–small cell lung cancer.
Emerging Targets in Non-Small Cell Lung Cancer - PMC
The combination of amivantamab and lazertinib was recently FDA-approved for first-line treatment of EGFR-mutated advanced NSCLC based on the ...
Research progress and challenges in the treatment of ...
In contrast, the 5-year survival rate of patients with advanced non-small cell lung cancer (NSCLC) is markedly lower. Hence, to increase the ...
Clinical Trial 23579
The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in ...
Efficacy and Safety of Olomorasib in Combination with ...
Olomorasib + pembrolizumab demonstrated manageable safety and promising antitumor activity in patients with KRAS G12C-mutant advanced NSCLC ...
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clinicaltrials.med.nyu.edu
clinicaltrials.med.nyu.edu/clinicaltrial/2888/phase-12-study-evaluating/A Phase 1/2 Study Evaluating the Safety and Efficacy of ...
In this study, two medicines, Amivantamab and Olomorasib, are used together to treat this type of lung cancer (KRAS G12C-mutated metastatic NSCLC). Amivantamab ...
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