Praveen Kumar Marimuthu: Phase 2 trial Carboplatin, Pemetrexed, Cetuximab for advanced NSCLC

Praveen Kumar Marimuthu, Final year Medical Oncology Trainee at CMC Vellore, shared on X:

“OPEN FOR TRIAL RECRUITMENT

 We, from Medical Oncology CMC Vellore, are recruiting eligible patients for our phase 2 trial Carboplatin, Pemetrexed with Cetuximab for advanced NSCLC with EGFR exon 20 insertion (CATCH20)’.

This multi-centric prospective phase II clinical trial will assess the efficacy and safety of Carboplatin, Pemetrexed with Cetuximab for locally advanced or metastatic adenocarcinoma lung with EGFR exon 20 insertion in the first line

Advanced NSCLC with EGFR exon 20 insertion mutation is under-studied in the Indian population, and there are no prospective Indian trials to date in this clinical setting.

The current standard of care – Amivantamab + chemotherapy for advanced NSCLC with EGFR exon 20 insertion is inaccessible to most patients in LMIC due to its exorbitant cost. Conventional EGFR TKIs or chemotherapy alone yield poor outcomes.

Pre-clinical modeling showed that EGFR exon 20 insertions brought dimerization domains closer together. Cetuximab acts by interfering with the dimerization of receptors. Cetuximab elicited a good response for patients with ex20ins in phase II trials and multiple case series.

In LMICs, where the current standard of care is inaccessible, there is a significant demand for alternative first-line therapies among EGFR ex20ins NSCLC patients, necessitating an urgent need for this project to address this gap

We plan to recruit 20 patients over 12-18 months. We are starting recruitment at CMC Vellore from next week. Four other institutions have expressed interest; recruitment will begin at other centers after respective IRB approvals.

Source: Praveen Kumar Marimuthu/X