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RMC-4630 + Sotorasib for Lung Cancer
Study Summary
This trial will test two drugs to see if they can shrink tumors in people with a certain type of lung cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 1 & 2 trial • 113 Patients • NCT03989115Trial Design
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Who is running the clinical trial?
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- I have or might have cancer spread to my brain, spinal cord, or its coverings.My cancer originated in the brain or spinal cord.I have a serious heart condition.I have been treated for an autoimmune disease in the last 2 years.I have a digestive issue that affects how my body absorbs medicine.I am 18 years old or older.I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.I have previously been treated with a KRASG12C or SHP2 inhibitor.My advanced lung cancer has a specific KRASG12C mutation and has worsened despite up to 3 treatments.
- Group 1: RMC-4630 and sotorasib, Safety Run-in
- Group 2: RMC-4630 and sotorasib, Expansion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the Food and Drug Administration authorized RMC-4630 for distribution?
"Our team at Power assessed RMC-4630's safety to be a 2, as Phase 2 trials have no efficacy data but some evidence of the drug being safe."
Are there still openings for participants in this experiment?
"According to clinicaltrials.gov, this experiment is actively recruiting individuals and was first advertised on December 30th 2021 with the most recent update occuring November 18th 2022."
What is the total enrollment of participants for this clinical investigation?
"In order to launch the trial, Sanofi must recruit 46 eligible candidates. This pharmaceutical company will be running this study at Clinical Research Alliance's New york branch and BRCR Medical Center Inc.'s Plantation centre in Florida."
How widespread is the implementation of this clinical trial across Canadian hospitals?
"Clinical Research Alliance, Inc. in New york, BRCR Medical Center Inc. in Plantation and Coleman, Pasmantier and Decter, Mds in Scarborough are three of the 24 available trial sites for this study; an additional 21 can be found across America as well."
What therapeutic objectives is RMC-4630 primarily utilized to achieve?
"RMC-4630 has been approved for the treatment of conditions previously treated with platinum therapy. Additionally, it is prescribed to those who have undergone a therapeutic procedure, previous systemic therapies and neoplasms malignant in nature."
Has a study like this been done before?
"The pharmaceutical drug RMC-4630 has been under clinical trial since 2018, with 11 active trials occurring in 632 cities and 28 countries. The initial study was funded by Amgen for 713 participants and successfully completed Phase 1 & 2 of FDA approval. Subsequently, 6 additional trials have concluded their studies."
Are there any previous experiments that have utilized RMC-4630?
"RMC-4630, which was initially investigated in 2018 at Centre Hospitalier Intercommunal de Créteil, has gone through 6 trials to date. At present there are 11 active clinical studies taking place with multiple sites located in New york City."
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