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Small Molecule Inhibitor

LY3537982 for Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have disease with evidence of KRAS G12C mutation in tumor tissue or circulating tumor deoxyribonucleic acid (DNA)
Participants must have a histological or a cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and meet cohort-specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up estimated up to 2 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new drug to see if it's safe and effective in cancer patients with a specific genetic mutation. Patients who have already tried the standard of care and couldn't tolerate it are eligible. The trial will last up to 2 years.

Who is the study for?
This trial is for cancer patients with a KRAS G12C mutation who've tried or can't tolerate standard treatments. It's open to those with certain cancers, like pancreatic and lung, if they have measurable disease, good organ function, an ECOG status of 0 or 1, and agree to use contraception. Some untreated NSCLC patients may join under specific conditions.Check my eligibility
What is being tested?
The study tests LY3537982's safety and effectiveness in treating various cancers with the KRAS G12C mutation. Patients will also receive other drugs like Pemetrexed and Pembrolizumab depending on their condition. The trial aims to include participants for up to four years.See study design
What are the potential side effects?
Potential side effects could include reactions related to the immune system due to Pembrolizumab, issues from chemotherapy agents like Pemetrexed (nausea, fatigue), as well as risks associated with new drug LY3537982 which are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has a KRAS G12C mutation.
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My cancer is advanced, cannot be surgically removed, and/or has spread.
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I am fully active or can carry out light work.
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I have had treatment with oxaliplatin or irinotecan for advanced colorectal cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~estimated up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and estimated up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY3537982 monotherapy
Phase 1b: To assess the safety and tolerability of LY3537982 when administered alone or in combination with other investigational agents
Phase 1b: To determine the optimal dose of LY3537982 to be administered to treatment-naïve participants with advanced NSCLC in combination with pembrolizumab
+2 more
Secondary outcome measures
To assess preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Objective response rate (ORR)
To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Best Overall Response (BOR)
To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Disease control rate (DCR)
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: LY3537982 (Dose Expansion)Experimental Treatment6 Interventions
LY3537982 administered orally either alone or with another investigational agent.
Group II: LY3537982 (Dose Escalation)Experimental Treatment1 Intervention
LY3537982 administered orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5250
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Cetuximab
2011
Completed Phase 3
~2480
LY3537982
2023
Completed Phase 1
~100
Pembrolizumab
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,597 Previous Clinical Trials
3,185,724 Total Patients Enrolled
Loxo Oncology, Inc.Industry Sponsor
65 Previous Clinical Trials
9,559 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,847 Previous Clinical Trials
5,045,472 Total Patients Enrolled

Media Library

LY3537982 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04956640 — Phase 1 & 2
Colorectal Cancer Research Study Groups: LY3537982 (Dose Escalation), LY3537982 (Dose Expansion)
LY3537982 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04956640 — Phase 1 & 2
Colorectal Cancer Clinical Trial 2023: LY3537982 Highlights & Side Effects. Trial Name: NCT04956640 — Phase 1 & 2

Frequently Asked Questions

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

How many locations have initiated this clinical trial?

"The current clinical trial seeks to enroll patients at various sites, such as South Texas Accelerated Research Therapeutics (START) in San Antonio, TX; Yale University School of Medicine in New Haven, CT; and NYU Langone in New york City. Additionally, there are 20 other medical centres participating."

Answered by AI

Are there still opportunities for participants to join this research project?

"As per the information hosted on clinicaltrials.gov, this research endeavour is actively seeking out enrollees. The trial was initially shared on July 19th 2021 and has since been amended as of November 11th 2022."

Answered by AI

Are there any limitations in terms of the number of enrollees for this clinical trial?

"Affirmative. The information found on clinicaltrials.gov confirms that this medical research project, which was launched in July of 2021, is currently enrolling volunteers. Approximately 360 patients need to be recruited from 23 different healthcare facilities."

Answered by AI

Has the Food and Drug Administration granted its stamp of approval to LY3537982?

"As LY3537982 is only in its initial testing stage, our team at Power has assigned it a score of 1 due to the current scarcity of data indicating safety and efficacy."

Answered by AI

What medical maladies is LY3537982 generally recommended to treat?

"LY3537982 is a common medical treatment for metastatic squamous cell carcinoma of the head and neck (hnscc) as well as malignant neoplasms, pancreatic cancer, and chemotherapy-induced disease progression."

Answered by AI

What are the ultimate goals of this clinical experiment?

"The primary aim of this 21 day clinical trial is to analyse the safety and acceptability of LY3537982 when administered independently or in union with alternative investigational treatments. Secondary objectives comprise establishing early antitumor activity by measuring Disease Control Rate (DCR), Progression-free Survival (PFS) as well as evaluating Maximum Drug Concentration (Cmax)."

Answered by AI

Is LY3537982 being trialed as part of any other clinical research projects?

"LY3537982 was first trialled at Mayo Clinic in Rochester back in the year 2002. This medicinal agent has since been scrutinized through 992 clinical studies, with 389 of these surveys currently enrolling patients - a large portion being undertaken out of San Antonio, Texas."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Hoag Memorial Hospital Presbyterian
What portion of applicants met pre-screening criteria?
Met criteria
~165 spots leftby Sep 2025