Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer

Shanghai JMT-Bio

Status and phase: Unknown; Phase 1

Conditions: Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Treatments: Drug: JMT101

Study type: Interventional

Funder types: Industry

Identifiers

NCT04448379

JMT101-CSP-001

Details and patient eligibility

About

This study is a Phase Ib, open label, multi-center study of to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (Afatinib or Osimertinib) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.

Full description

The objective of the trial is to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (afatinib or osimertinib) in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.

This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study, and Stage II was a dose expansion study.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically or cytologically confirmed, locally advanced or metastatic NSCLC, harboring an EGFR exon 20 insertion mutation. ( non-irradiable, non-operable);
• No previous treatment or first-line treatment failed NSCLC;
• At least 1 measurable lesion according to RECIST 1.1;
• ECOG score 0 or 1;

Exclusion criteria

• Previously treated with EGFR antibody;
• Symptomatic brain metastasis;
• Interstitial pneumopathy;
• Known hypersensitivity to any ingredient of JMT101, afatinib, osimertinib or their excipients;
• Receiving an investigational product in another clinical study within 4 weeks;
• History of serious systemic diseases;
• History of serious autoimmune diseases;
• Pregnancy or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Dose Escalation Cohort

Experimental group

Description:

Two dose levels of JMT101 combined with afatinib or osimertinib will be tested according to the "3 + 3" dose-escalation design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).

Treatment:

Drug: JMT101

Dose Expansion Cohort

Experimental group

Description:

Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.

Treatment:

Drug: JMT101