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Small Molecule Inhibitor

RMC-4630 + Sotorasib for Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by Revolution Medicines, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must be ≥18 years of age.
Subject must have pathologically documented, locally advanced or metastatic KRASG12C NSCLC (not amenable to curative surgery) that has progressed on prior standard therapies (no more than 3 prior lines of therapies are allowed)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 12 months
Awards & highlights

Study Summary

This trial will test two drugs to see if they can shrink tumors in people with a certain type of lung cancer.

Who is the study for?
This trial is for adults over 18 with advanced or metastatic KRASG12C mutant Non-Small Cell Lung Cancer (NSCLC) that worsened after standard treatments. They must not have had more than three prior therapies, no brain tumors or severe heart disease, and can't have taken drugs targeting KRASG12C or SHP2 before.Check my eligibility
What is being tested?
The study tests the combination of two drugs, RMC-4630 and Sotorasib, to see their effectiveness against NSCLC with a specific mutation (KRASG12C). It's for patients who've tried other treatments without success.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drug components, issues from drug interactions affecting the heart or gastrointestinal system, and complications related to autoimmune diseases if previously treated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
My advanced lung cancer has a specific KRASG12C mutation and has worsened despite up to 3 treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Adverse Events
Clinical laboratory test values
Concentration of RMC-4630
+8 more

Side effects data

From 2022 Phase 1 & 2 trial • 113 Patients • NCT03989115
92%
diarrhoea
42%
dyspnoea
42%
anaemia
33%
oedema peripheral
25%
cough
25%
fatigue
25%
thrombocytopenia
25%
pleural effusion
25%
pyrexia
25%
nausea
17%
constipation
17%
myocardial infarction
17%
ascites
17%
dizziness
17%
dry eye
17%
hypotension
17%
vomiting
17%
abdominal pain
17%
dry mouth
17%
aspartate aminotransferase increased
17%
platelet count decreased
17%
blood creatine phosphokinase increased
17%
hypomagnesaemia
17%
weight increased
17%
dermatitis acneiform
8%
blood uric acid decreased
8%
dry skin
8%
hypouricaemia
8%
decreased appetite
8%
hyponatraemia
8%
urinary tract infection
8%
haematuria
8%
dyspepsia
8%
toothache
8%
hernia
8%
upper respiratory tract infection
8%
sepsis
8%
abdominal distention
8%
pruritus
8%
hair colour changes
8%
hypoalbuminaemia
8%
stomatitis
8%
syncope
8%
rash maculo-papular
8%
fall
8%
asthenia
8%
chills
8%
ileus paralytic
8%
dehydration
8%
face oedema
8%
generalised oedema
8%
blood alkaline phosphatase increased
8%
white blood cell count decreased
8%
rash
8%
pneumonia
8%
leukopenia
8%
periorbital oedema
8%
wheezing
8%
neutrophil count decreased
8%
protein total decreased
8%
hypocalcaemia
8%
hypoproteinaemia
8%
neuropathy peripheral
8%
hypoaesthesia
8%
bronchitis
8%
acute kidney injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)

Trial Design

2Treatment groups
Experimental Treatment
Group I: RMC-4630 and sotorasib, Safety Run-inExperimental Treatment2 Interventions
Safety Run-In: RMC-4630 and sotorasib
Group II: RMC-4630 and sotorasib, ExpansionExperimental Treatment2 Interventions
Dose Expansion: RMC-4630 and sotorasib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RMC-4630
2019
Completed Phase 2
~120
Sotorasib
2021
Completed Phase 1
~370

Find a Location

Who is running the clinical trial?

Revolution Medicines, Inc.Lead Sponsor
10 Previous Clinical Trials
2,015 Total Patients Enrolled
SanofiIndustry Sponsor
2,158 Previous Clinical Trials
3,514,301 Total Patients Enrolled
AmgenIndustry Sponsor
1,355 Previous Clinical Trials
1,384,024 Total Patients Enrolled

Media Library

RMC-4630 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05054725 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: RMC-4630 and sotorasib, Safety Run-in, RMC-4630 and sotorasib, Expansion
Non-Small Cell Lung Cancer Clinical Trial 2023: RMC-4630 Highlights & Side Effects. Trial Name: NCT05054725 — Phase 2
RMC-4630 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05054725 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~15 spots leftby Mar 2025