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DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer

NCT03255083 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-01-19

Study results available
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Summary

This study has two parts: dose escalation and dose expansion.

The primary objectives are:

* For Dose Escalation, to assess the safety and tolerability of DS-1205c when combined with osimertinib in the study population and to determine the recommended dose for expansion of DS-1205c when combined with osimertinib in the study population
* For Dose Expansion, to assess the safety and tolerability of DS-1205c when combined with osimertinib in the study population

In Dose Escalation, after a 7-day run in period (Cycle 0), there will be 21-day cycles (Cycle 1 onward). In Dose Expansion, there will be 21-day cycles.

The number of treatment cycles is not fixed in this study. Participants will continue study treatment until they decide not to (withdraw consent), their disease gets worse \[progressive disease (PD)\], or side effects become unacceptable (unacceptable toxicity).

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Interventions

DRUG

DS-1205c

DS-1205c 200 mg capsule

DRUG

Osimertinib

Osimertinib 80 mg tablet

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2020-09-04
Completion
2020-09-04

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03255083 on ClinicalTrials.gov