LY3537982

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Ying Cheng

Jianying Zhou

Xinmin Yu

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

This is an open-label, single-arm, multicenter, Phase 1 study of LY3537982 as monotherapy in Chinese participants with KRAS G12C-mutant advanced solid tumors. The main purpose of this study is to determine how much of LY3537982 gets into the bloodstream and how long it takes the body to eliminate it in Chinese participants. The safety, tolerability and preliminary efficacy of LY3537982 will also be evaluated. Approximately 12 patients will be enrolled in this study.

A Study of LY3537982 in Chinese Participants With Advanced Solid Tumors

An Open-label, Single-arm, Multicenter, Phase 1 Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Antitumor Activity of LY3537982 in Chinese Patients With KRAS G12C-Mutant Advanced Solid Tumors

ORR: ORR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).

DCR: DCR assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).

PFS: PFS assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1).

Eli Lilly and Company

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Carcinoma

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Carboplatin

Pemetrexed

Pembrolizumab

Cisplatin

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

LY3537982 Dose level 1 administered orally in combination with pembrolizumab administered intravenously (IV) in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

LY3537982 Dose level 2 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

LY3537982 administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

LY3537982 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Placebo administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Placebo administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Placebo

Marshall Schreeder

Eric Schaefer

Kamya Sankar

Parminder Sidhu

Charity Huang

So Yeon Kim

Kristen Marrone

Isaac Levy

Paul Kaywin

Ketan D. Doshi

Neeharika Srivastava Makani

Noman Ashraf

Ticiana Leal

Frank Weinberg

Marina Garassino

Preet Singh

Gregory Durm

Natraj Ammakkanavar

Jun Zhang

Susanne Markesbery Arnold

Umit Tapan

Andrew Piper-Vallillo

Angel Qin

Dipesh Uprety

Yuanbin Chen

Charlene Marie Fares

Kurt Demel

Maurice Willis

Konstantin Dragnev

Sarada Gurubhagavatula

Eli Kirschner

Arturo Loaiza-Bonilla

Atul Kumar

Joshua Sabari

Morana Vojnic

James T D'Olimpio

Shetal Patel

Jeffrey Clarke

Brendan McNulty

Raid Aljumaily

Alison Savage

Rachel Sanborn

Sandeep Mashru

Sarah Gordon

Timothy Burns

Mariam Alexander

Osa Ogbeide

Warren Alexander

Jason Burris

Marcelo Vailati Negrao

Alan Gowan

Siddhartha Devarakonda

Matthew Ho Fai Wong

Adam Stirling

Bryan Chan

ZIA UL HAQ ANSARI

Robert Mason

Abhishek Joshi

Harminder Takhar

Wasek Faisal

Melissa Moore

Myron Klevansky

samantha bowyer

Michael Schumacher

Thomas Winder

Maximilian Hochmair

Kim De Muynck

Marc Lambrechts

Luciano Carestia

Sebahat Ocak

Veerle Surmont

christophe Dooms

Lander Van Acker

Katrien Ghysen

Patrick Alexander

Aknar Calabrich

Fabio Chaves

Luiza Faria

ROMUALDO BARROSO DE SOUSA

Antonio Machado Alencar

Marina Zorzetto

Fernanda Ronchi

Mariana Miyasaki Piovesana

Danielli de Almeida Matias

ANDRE REIRIZ

Fabio Andre Franke

Ana Caroline Zimer Gelatti

Claudia Vaz de Melo Sette

Marcelo Corassa

Emerson Neves dos Santos

Milena Perez Mak

Fabiano de Almeida Costa

Victor Marcondes Lopes dos Santos

Pedro Rafael Martins De Marchi

Gilberto Castro

Guilherme Harada

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.

Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single arm, non-randomized.

A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C

SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Dose Optimization and Safety Lead-In Part B: Number of Participants with a TEAE

PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)

NSCLC symptoms will be assessed using the 7-item NSCLC-SAQ. The NSCLC-SAQ measures overall symptom severity of NSCLC, including cough, pain, dyspnea, fatigue, and poor appetite. Response options range from 0) "Not at all" to 4) "Always" or from 0) "Never" to 4) "Always." The total score ranges from 0-20. Higher scores represent worse symptoms.

The EORTC QLQ-C30 is a 30-question patient-reported instrument used to assess multidimensional health-related quality of life (HRQoL) in cancer patients. Physical functioning is measured by the EORTC-QLQ-30 Physical Function Scale (five items). Response options range from 1) "Not at all" to 4) "Very much." The sum score is linearly transformed to the range 0 - 100. Higher scores represent better physical function.

FACT-GP5 is a single-item, patient-reported instrument for assessing overall treatment side-effect burden. Response options range from 0) "Not at all" to 4) "Very much." Higher scores represent higher symptom burden.

The EORTC QLQ-C30 is a 30-question patient-reported instrument used to assess multidimensional HRQoL in cancer patients. Overall HRQoL is measured by the EORTC QLQ-30 Global Health Status/Quality of Life Subscale (two items). Response options range from 1) "very poor" to 7) "excellent." Scores are linearly transformed to the range 0 - 100. Higher scores represent better overall HRQoL.

Loxo Oncology, Inc.

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Colorectal Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Endometrial Neoplasms

Biliary Tract Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Uterine Neoplasms

Uterine Diseases

Biliary Tract Diseases

Pancreatic Cancer

Ovarian Cancer

Cetuximab

LY3537982 administered orally either alone or with another investigational agent.

LY3537982 administered orally either alone or with another investigational agent

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of LY3537982 in Chinese Participants With Advanced Solid Tumors	NCT06235983	Advanced Solid ...	LY3537982	18 Years -	Eli Lilly and Company
A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C	NCT06119581	Carcinoma, Non-... Neoplasm Metast...	LY3537982 Pembrolizumab Placebo Cisplatin Carboplatin Pemetrexed	18 Years -	Eli Lilly and Company
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)	NCT04956640	Carcinoma, Non-... Colorectal Neop... Endometrial Neo... Ovarian Neoplas... Pancreatic Neop... Biliary Tract N...	LY3537982 Pembrolizumab Cetuximab Pemetrexed Cisplatin Carboplatin	18 Years -	Eli Lilly and Company
A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C	NCT06119581	Carcinoma, Non-... Neoplasm Metast...	LY3537982 Pembrolizumab Placebo Cisplatin Carboplatin Pemetrexed	18 Years -	Eli Lilly and Company
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)	NCT04956640	Carcinoma, Non-... Colorectal Neop... Endometrial Neo... Ovarian Neoplas... Pancreatic Neop... Biliary Tract N...	LY3537982 Pembrolizumab Cetuximab Pemetrexed Cisplatin Carboplatin	18 Years -	Eli Lilly and Company
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)	NCT04956640	Carcinoma, Non-... Colorectal Neop... Endometrial Neo... Ovarian Neoplas... Pancreatic Neop... Biliary Tract N...	LY3537982 Pembrolizumab Cetuximab Pemetrexed Cisplatin Carboplatin	18 Years -	Eli Lilly and Company
A Study of LY3537982 in Chinese Participants With Advanced Solid Tumors	NCT06235983	Advanced Solid ...	LY3537982	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for ly3537982

Every month we try and update this database with for ly3537982 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ly3537982

Every month we try and update this database with for ly3537982 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ly3537982 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.