A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

Browse trials for

• Carcinoma, Non-Small-Cell Lung 6,488

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 57 is close to the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Study arms

• Experimental
  Phase 1 (Combination Dose Selection)

  Participants will receive capmatinib 400 milligrams (mg) orally twice daily from Cycle 1 Day 1, in combination with amivantamab 700 mg intravenous (IV) infusion (for body weight less than 80 kilograms \[kg\]) or 1050 mg IV infusion (for body weight greater than or equal to 80 kg) once weekly from Cycle 1 Day 1 for 4 weeks and then every 2 weeks from Week 5 (Cycle 2; each cycle of 28 days). Doses will be escalated or de-escalated based on the dose limiting toxicities (DLTs) and the recommended Phase 2 combination dose (RP2CD) will be determined by the study evaluation team (SET).

  Drug: Capmatinib · Drug: Amivantamab

• Experimental
  Phase 2 (Dose Expansion)

  Participants with mesenchymal-epithelial transition (MET) exon 14 skipping mutation who are treatment naïve (Cohort 1A), who have received prior therapy (Cohort 1B), or participants with MET amplification who have received prior therapy (Cohort 1C) will receive capmatinib in combination with amivantamab at the RP2CD determined by the SET in Phase 1.

  Drug: Capmatinib · Drug: Amivantamab

Interventions

• DrugCapmatinib

  Capmatinib will be administered orally.

• DrugAmivantamab

  Amivantamab will be administered as IV infusion.

  Also known as: JNJ-61186372

Primary outcomes

1. Phase 1: Number of Participants with Adverse events (AEs) by Severity

   An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

   Time frame: Up to 2 years 1 month

2. Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)

   The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, hematologic toxicity, pulmonary toxicity, liver enzyme elevation, or treatment delay greater than (\>) 28 days due to unresolved toxicity.

   Time frame: Cycle 1 (Day 1 through Day 28)

3. Phase 2: Objective Response Rate

   ORR is defined as the percentage of participants who achieve either a confirmed partial response (PR) or complete response (CR), using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

   Time frame: Up to 2 years 1 month

Secondary outcomes

1. Phase 1: Number of Participants with AEs by Severity

   An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

   Time frame: Up to 2 years 1 month

2. Phase 1: Number of Participants with Abnormalities in Clinical Laboratory Parameters

   Number of participants with abnormalities in clinical laboratory parameters (serum chemistry, hematology, coagulation, serology, and urinalysis) will be reported.

   Time frame: Up to 2 years 1 month

3. Phase 2: Duration of Response (DoR)

   DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death from any case, whichever comes first, for participants who have PR or CR.

   Time frame: Up to 2 years 1 month

4. Phase 2: Disease Control Rate (DCR)

   DCR is defined as the percentage of participants who achieve a PR, CR, or stable disease using RECIST version 1.1.

   Time frame: Up to 2 years 1 month

5. Phase 2: Progression Free Survival (PFS)

   PFS is defined as the time from first dose date until the date of disease progression or death, whichever comes first, based on investigator assessment using RECIST version 1.1

   Time frame: Up to 2 years 1 month

6. Phase 2: Overall Survival (OS)

   OS is defined as the time from the date of administration of the first study treatment until the date of death due to any cause.

   Time frame: Up to 2 years 1 month

7. Phase 2: Time to Subsequent Therapy (TTST)

   TTST is defined as the time from the date of administration of the first study treatment to the start date of the subsequent anticancer therapy following study treatment discontinuation, or death, whichever comes first.

   Time frame: Up to 2 years 1 month

8. Phase 2 (Cohort 1A): Change from Baseline in Health-related Quality of Life in (HRQoL) as Assessed by European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score

   EORTC-QLQ-C30 is a self-administered, 30-item questionnaire developed to assess the HRQoL of cancer participants.

   Time frame: Baseline up to 2 years 1 month

9. Phase 2 (Cohort 1A): HRQoL as Assessed by Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ) Scale Score

   NSCLC-SAQ assesses patient-reported symptom severity associated with NSCLC.

   Time frame: Up to 2 years 1 month

10. Phase 2 (Cohort 1A): HRQoL as Assessed by EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale Score

    EQ-5D-5L is a self-administered, standardized measure of health status.

    Time frame: Up to 2 years 1 month

11. Phase 2 (Cohort 1A): HRQoL as Assessed by Patient-reported Outcomes Measurement Information System Short Form Version 2.0 - Physical Function 8c (PROMIS PF 8c) Scale Score

    PROMIS PF 8c is an 8-item fixed length short form derived from the PROMIS Physical Function item bank. It assesses activities of daily living, mobility, and global impact of physical functioning.

    Time frame: Up to 2 years 1 month

Individual participant data

Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu