CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 48 target
Drug / intervention
inetetamab +1 moredrug
Likely dose
inetetamab 8 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05016544
NCT05016544Phase 2Unknown

A Phase Ib Clinical Study Evaluating the Safety and Efficacy of Inetetamab in Combination With Pyrotinib in HER2 Mutant or Amplified Patients With Advanced Non-small Cell Lung Cancer

Sun Yat-sen University·interventional·Posted Aug 23, 2021·Updated Aug 23, 2021

In Brief

A Phase 2 clinical trial evaluating inetetamab and Pytotinib for Non-small Cell Lung Cancer. Targeting 48 participants across 1 site.

Detailed Summary

This is a Phase 1, open-label study to evaluate the safety and the efficacy of inetetamab in combination with pyrotinib in patients in HER2 mutant or amplified patients with advanced non-small cell lung cancer

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2UnknownOverdue
20222023202420252026
First PostedAug 23, 2021
Enrollment StartJul 28, 2021
Primary CompletionAug 1, 2023
Study CompletionFeb 1, 2025
TodayJul 1, 2026
Enrollment to primary: 2.0 yearsPosted 4.9 years ago

Interventions

inetetamabdrug

All dose levels will receive 8 mg/kg loading dose for cycle 1, followed by 6 mg/kg in subsequent cycles, every 3 weeks.

Pytotinibdrug

Starting pytotinib Dose of 240mg: Cohort 1: pyrotinib 240mg p.o. d1 to d21, q3w; Cohort 2: pyrotinib 320mg p.o. d1 to d21, q3w; Cohort 3: pyrotinib 400mg p.o. d1 to d21, q3w.