Durvalumab for Lung Cancer

(ATLANTIC Trial)

Recruiting at 123 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Must not be taking: Steroids

Disqualifiers: Brain metastases, Autoimmune disease, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 months

446 Participants Needed

Trial Summary

What is the purpose of this trial?

A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability

Research Team

Phillip Dennis, MD, PhD

Principal Investigator

AstraZeneca

Eligibility Criteria

This trial is for adults over 18 with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have already tried a platinum-based chemotherapy and one other treatment without success. They should be relatively healthy (WHO Performance Status of 0 or 1), expected to live more than 12 weeks, and their tumors must show certain levels of PD-L1 protein.

Inclusion Criteria

I am 18 years old or older.

My tumor is PD-L1 positive with specific levels of cell staining.

My lung cancer is at an advanced stage (IIIB or IV).

Exclusion Criteria

I have been treated with drugs targeting PD-1 or PD-L1 before.

I don't have severe side effects from past cancer treatments.

My brain or spinal cord cancer is stable and doesn't require steroids.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MEDI4736 (Durvalumab) on a Q2W schedule for a maximum of 12 months

12 months

Visits every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years 3 months

Long-term follow-up

Participants are monitored for overall survival

up to 3 years 8 months

Treatment Details

Interventions

• MEDI4736

Trial Overview The study tests the effects of MEDI4736 (Durvalumab), focusing on how well it works, its safety, and how tolerable it is for patients with NSCLC that's either locally advanced or has spread to other parts of the body.

Participant Groups

Group I: MEDI4736 Experimental Treatment 1 Intervention

see below

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology