A Phase II, Non-comparative, Open label, Multi-centre, International Study of MEDI4736, in Patients with Locally Advanced or Metastatic Non‑Small Cell Lung Cancer (Stage IIIB-IV) who have received at least Two Prior Systemic Treatment Regimens Including One Platinum-based Chemotherapy Regimen (ATLANTIC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512379-10-00

Acronym

D4191C00003

Enrollment

Registered

2024-05-22

Start date

2014-09-23

Completion date

2025-03-26

Last updated

2025-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIBIV)

Brief summary

Objective response rate (ORR) (per RECIST 1.1) Timepoint(s) of evaluation of this end point For each cohort, the data cut-off for the analysis of ORR will take place approximately 24 weeks after the last patient is enrolled into each cohort.

Detailed description

- Duration of response - Progression free survival - Disease control rate - Overall survival - Deep sustained response - AEs Timepoint(s) of evaluation of this end point The data cut-off for analysis of the secondary efficacy endpoints will take place approximately 8 months after recruitment ends. The final analysis of OS (secondary endpoint) will take place approximately 12 months after the last patient is enrolled into each cohort.

Interventions

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) (per RECIST 1.1) Timepoint(s) of evaluation of this end point For each cohort, the data cut-off for the analysis of ORR will take place approximately 24 weeks after the last patient is enrolled into each cohort.	—

Secondary

Measure	Time frame
- Duration of response - Progression free survival - Disease control rate - Overall survival - Deep sustained response - AEs Timepoint(s) of evaluation of this end point The data cut-off for analysis of the secondary efficacy endpoints will take place approximately 8 months after recruitment ends. The final analysis of OS (secondary endpoint) will take place approximately 12 months after the last patient is enrolled into each cohort.	—

Measure

Time frame

—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026