Ivonescimab + Chemotherapy for NSCLC
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to assess the efficacy of ivonescimab monotherapy in patients with advanced non-small cell lung cancer harboring actionable genomic alterations who have received prior targeted therapies and chemotherapy. This clinical trial also aims to assess the efficacy of ivonescimab plus carboplatin/pemetrexed chemotherapy in patients with advanced non-small cell lung cancer harboring actionable genomic alterations other than epidermal growth factor receptor mutations who have received prior targeted therapies but no chemotherapy. The main questions it aims to answer are:
* Will ivonescimab alone or together with carboplatin/pemetrexed chemotherapy shrink tumors in the clinical trial's patients?
* Will ivonescimab alone or together with carboplatin/pemetrexed chemotherapy effectively influence if the patients' cancer grows, how long the treatment takes to start working, how long the treatment keeps working after it first starts to help, how long the treatment keeps the cancer from getting worse, and overall survival of patients?
* How many patients receiving ivonescimab alone or together with carboplatin/pemetrexed chemotherapy will experience treatment-emergent, treatment-related, immune-related, and especially interesting side effects? Patients receiving ivonescimab alone will receive an intravenous infusion of ivonescimab every 3 weeks for up to 24 months. Patients receiving ivonescimab together with carboplatin/pemetrexed chemotherapy will receive separate intravenous infusions of ivonescimab, pemetrexed, and carboplatin every 3 weeks for 4 cycles (each cycle is 21 days). These patients will continue to receive infusions of ivonescimab and pemetrexed every 3 weeks for up to 24 total months.
Who Is on the Research Team?
Jessics J Lin, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
Adults (18+) with advanced non-squamous NSCLC, specific genomic alterations, and prior targeted therapy can join. Those for ivonescimab monotherapy must have had platinum/pemetrexed chemo; those for the combo treatment shouldn't have had chemo but must've tried certain TKIs. Participants need a measurable tumor, may have stable brain metastases, good performance status (ECOG 0 or 1), and adequate organ function.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ivonescimab monotherapy or ivonescimab with carboplatin/pemetrexed chemotherapy every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Ivonescimab
- Pemetrexed
Trial Overview
The trial is testing if ivonescimab alone or combined with carboplatin/pemetrexed chemotherapy can shrink tumors in NSCLC patients with certain genomic changes. It looks at cancer progression, response duration, time to effect onset, disease control period, and overall survival rates.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients with advanced/metastatic non-small cell lung cancer harboring actionable genomic alterations other than epidermal growth factor receptor mutations with disease progression after prior targeted therapies but no prior chemotherapy will receive ivonescimab, carboplatin, and pemetrexed. Ivonescimab will be administered at the pre-determined dose with the pre-determined doses of carboplatin and pemetrexed on day 1 of the first 4 treatment cycles (each cycle is 21 days) or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurs first. Patients who have stable disease or response after the first 4 treatment cycles will continue to receive pre-determined doses of ivonescimab and pemetrexed every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or for up to 24 months, whichever occurs first.
Patients with advanced/metastatic non-small cell lung cancer harboring actionable genomic alterations with disease progression after prior targeted therapies and chemotherapy will receive ivonescimab monotherapy. Ivonescimab will be administered at the pre-determined dose every 3 weeks on day 1 of each cycle (each cycle is 21 days) until disease progression, unacceptable toxicity, withdrawal of consent, or for up to 24 months, whichever occurs first.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Summit Therapeutics
Industry Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.