The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival, in participants treated with amivantamab in combination with chemotherapy vs chemotherapy alone in participants with locally advanced or metastatic NSCLC characterized by EGFR Exon 20ins mutations.

Phase 3

Active, not recruiting

• Conditions: Malignant neoplasm of unspecifiedpart of bronchus or lung,

• Registration Number: CTRI/2020/11/029081
• Lead Sponsor: Johnson and Johnson Private Limited

Brief Summary

The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC)

characterized by EGFR Exon 20ins mutations.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation.
• Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream.

Exclusion Criteria

• Participant has evidence of synchronous NSCLC with an EGFR mutation other than EGFR Exon 20ins.
• Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible).
• Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation.
• Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis.
• Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review	Up to 18 months

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	Up to 48 months
Duration of Response	Up to 48 months
Overall Survival	Up to 48 months
Time to Subsequent Therapy	Up to 48 months
Progression-Free Survival After First Subsequent Therapy	Up to 48 months
Time to Symptomatic Progression	Up to 48 months
Incidence and Severity of Adverse Events	Up to 48 months
Number of Participants with Clinical Laboratory Abnormalities	Up to 48 months
Number of Participants with Vital Signs Abnormalities	Up to 48 months
Number of Participants with Physical Examination Abnormalities	Up to 48 months
Serum Concentration of Amivantamab	Up to 48 months
Number of Participants with Anti-Amivantamab Antibodies	Up to 48 months
European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30	Up to 48 months
Patient Reported Outcomes Measurement Information System-Physical Function	Up to 48 months

Trial Locations

Locations (6)

Basavatarakam Indo American Centre Hospital and Research Institute; 🇮🇳 Hyderabad, TELANGANA, India

HCG Manavata Cancer Center; 🇮🇳 Nashik, MAHARASHTRA, India

Noble Hospital Pvt Ltd; 🇮🇳 Pune, MAHARASHTRA, India

Rajiv Gandhi Cancer Institute & Research Centre; 🇮🇳 Delhi, DELHI, India

Tata Medical Center; 🇮🇳 Kolkata, WEST BENGAL, India

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Basavatarakam Indo American Centre Hospital and Research Institute

🇮🇳Hyderabad, TELANGANA, India

Dr M V T Krishna Mohan

Principal investigator

9866154503

mvtkm@yahoo.com