Clinical Trial: NCT04538664
A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Janssen Research & Development, LLC |
| Information Provided By: | Janssen Research & Development, LLC |
| Last Update Posted: | 2026-08-31 |
Study Overview
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.
Official Title
A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Conditions
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment
- Drug: Amivantamab
- Drug: Pemetrexed
- Drug: Carboplatin
- Drug: Pemetrexed
Other Study ID Numbers
- CR108850
- 61186372NSC3001
- 2020-000633-40
- 2023-506033-29-00
- 2023
Start Date (Actual)
2020-10-13
Primary Completion Date (Actual)
2023-05-03
Study Completion Date (Estimated)
2027-08-02
Enrollment (Actual)
308
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Janssen Research & Development, LLC |
| Information Provided By: | Janssen Research & Development, LLC |
| Last Update Posted: | 2026-08-31 |
Study Overview
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.
Official Title
A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Conditions
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment
- Drug: Amivantamab
- Drug: Pemetrexed
- Drug: Carboplatin
- Drug: Pemetrexed
Other Study ID Numbers
- CR108850
- 61186372NSC3001
- 2020-000633-40
- 2023-506033-29-00
- 2023
Start Date (Actual)
2020-10-13
Primary Completion Date (Actual)
2023-05-03
Study Completion Date (Estimated)
2027-08-02
Enrollment (Actual)
308
Study Type
Interventional
Phase
Phase 3