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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
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.
Study details:
Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single arm, non-randomized.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-12-21
Primary completion: 2026-10-01
Study completion finish: 2029-10-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06119581
Intervention or treatment
DRUG: LY3537982
DRUG: Pembrolizumab
DRUG: Placebo
DRUG: Cisplatin
DRUG: Carboplatin
DRUG: Pemetrexed
Conditions
- • Carcinoma, Non-Small-Cell Lung
- • Neoplasm Metastasis
Find a site
Closest Location:
Gosford Hospital
Research sites nearby
Select from list below to view details:
Gosford Hospital
Gosford, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Mackay Base Hospital
Mackay, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Dose Optimization: LY3537982 Dose Level 1 plus Pembrolizumab
| DRUG: LY3537982
|
EXPERIMENTAL: Dose Optimization: LY3537982 Dose Level 2 plus Pembrolizumab
| DRUG: LY3537982
|
EXPERIMENTAL: Safety Lead In: LY3537982 plus Pembrolizumab, Pemetrexed and Platinum
| DRUG: LY3537982
|
EXPERIMENTAL: Part A: LY3537982 plus Pembrolizumab
| DRUG: LY3537982
|
PLACEBO_COMPARATOR: Part A: Placebo plus Pembrolizumab
| DRUG: Pembrolizumab
|
EXPERIMENTAL: Part B: LY3537982 plus Pembrolizumab, Pemetrexed, and Platinum
| DRUG: LY3537982
|
PLACEBO_COMPARATOR: Part B: Placebo plus Pembrolizumab, Pemetrexed, and Platinum
| DRUG: Pembrolizumab
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE) | Dose Optimization and Safety Lead-In Part B: Number of Participants with a TEAE | Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year) |
Part A and Part B: Progression-Free Survival (PFS) | PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR) | Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year) |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Part A and Part B: Overall Survival (OS) | Part A and Part B: OS | Randomization to date of death from any cause. (Estimated as up to 3 years) |
Part A and Part B: Overall Response Rate (ORR): Percentage of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) | ORR per RECIST v1.1 by BICR | Randomization to disease progression or death. (Estimated as approximately 1 year) |
Part A and Part B: Duration of Response (DOR) | DOR per RECIST v1.1 by BICR | Date of first evidence of CR or PR to date of disease progression or death from any cause. (Estimated as approximately 1 year) |
Part A and Part B: Disease Control Rate (DCR): Percentage of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD) | DCR per RECIST v1.1 by BICR | Randomization to disease progression or death from any cause. (Estimated as approximately 1 year) |
Part A and Part B: Time to Response (TTR) | TTR per RECIST v1.1 by BICR | Time from randomization until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 1 year) |
Part A and Part B: PFS2 | Part A and Part B: PFS2 by Investigator | Randomization to disease progression on next line of treatment or death from any cause (Estimated as approximately 1 year |
Part A and Part B: Time to Worsening of NSCLC-related Symptoms as Measured by NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ) | 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. | Randomization through end of treatment (Estimated as approximately 1 year) |
Part A and Part B: Time to Deterioration in Physical Function, as Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning Subscale | 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. | Randomization through end of treatment (Estimated as approximately 1 year) |
Part A and Part B: Proportion of Time with High Side-Effect Burden, as Measured by Functional Assessment of Cancer Therapy - General Item 5 (FACT-GP5) | 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. | Randomization through end of treatment (Estimated as approximately 1 year) |
Part A and Part B: Change from Baseline in Overall Health-related Quality of Life, as Measured by the EORTC QLQ-C30 Global Health Status/Quality of Life Subscale | 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. | Randomization through end of treatment (Estimated as approximately 1 year) |
Frequently Asked Questions
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