LY3537982 for Non-Small-Cell Lung Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-Small-Cell Lung Carcinoma+4 MoreLY3537982 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Non-Small-Cell Lung Carcinoma
  • Endometrial Cancer
  • Pancreatic Cancer
  • Colorectal Cancer
  • Ovarian Tumors

Video Summary

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Estimated up to 2 years

Cycle 1 (21 Days)
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
Year 2
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)
To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Duration of Response (DOR)
To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Overall survival (OS)
To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Progression-free survival (PFS)
To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Time to response (TTR)
Year 2
To characterize the PK properties of LY3537982: Maximum drug concentration (Cmax)
To characterize the pharmacokinetics (PK) properties of LY3537982: Area under the plasma concentration versus time curve (AUC)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

LY3537982 (Dose Expansion)
1 of 2
LY3537982 (Dose Escalation)
1 of 2

Experimental Treatment

360 Total Participants · 2 Treatment Groups

Primary Treatment: LY3537982 · No Placebo Group · Phase 1

LY3537982 (Dose Expansion)Experimental Group · 9 Interventions: Erlotinib, Sintilimab, Abemaciclib, TNO155, Pembrolizumab, Cetuximab, LY3295668, LY3537982, Temuterkib · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
LY3537982 (Dose Escalation)
Drug
Experimental Group · 1 Intervention: LY3537982 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erlotinib
FDA approved
Sintilimab
Not yet FDA approved
Abemaciclib
FDA approved
Pembrolizumab
2017
Completed Phase 3
~2240
Cetuximab
FDA approved
LY3295668
2017
Completed Phase 2
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: estimated up to 2 years

Who is running the clinical trial?

Loxo Oncology, Inc.Industry Sponsor
41 Previous Clinical Trials
7,183 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,673 Previous Clinical Trials
4,958,544 Total Patients Enrolled
Eli Lilly and CompanyLead Sponsor
2,466 Previous Clinical Trials
3,135,042 Total Patients Enrolled
Melinda Willard, PhDStudy DirectorLoxo Oncology, Inc.

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients must have measurable disease per RECIST v1.1.
You have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
You have discontinued all previous treatments for cancer with resolution of any significant ongoing AEs.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Hoag Memorial Hospital Presbyterian100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%