Durvalumab for Lung Cancer

(ATLANTIC Trial)

No longer recruiting at 157 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new treatment called MEDI4736 (also known as Durvalumab, an immunotherapy drug) for individuals with Non-Small Cell Lung Cancer (NSCLC). Researchers aim to determine the safety and efficacy of this treatment for lung cancer that has progressed after other therapies. Only patients with tumors showing a specific marker (PD-L1 positive) are eligible, particularly if the cancer has returned after previous treatments. The study seeks individuals who have experienced disease progression despite undergoing platinum-based chemotherapy and at least one other treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that durvalumab, also known as MEDI4736, has been studied for its safety in treating non-small cell lung cancer (NSCLC). In earlier studies, patients generally tolerated durvalumab well. Common side effects include tiredness and cough, but these are usually manageable.

The PACIFIC trial, a major study, used durvalumab after chemotherapy and radiation for patients with stage III NSCLC that cannot be surgically removed. This study confirmed the long-term safety of durvalumab, supporting its use as a standard treatment in these cases. Additionally, another large study further supported its safety and effectiveness for similar conditions.

While various studies continue to test durvalumab, current evidence provides a strong basis for its safety in lung cancer treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Durvalumab is unique because it is an immunotherapy that targets the PD-L1 protein, which helps cancer cells hide from the immune system. Unlike the standard chemotherapy treatments for lung cancer that attack cancer cells directly, Durvalumab helps the body's own immune system recognize and fight the cancer. Researchers are excited because this mechanism of action could lead to fewer side effects and potentially longer-lasting responses in patients.

What evidence suggests that this treatment might be an effective treatment for lung cancer?

Research shows that durvalumab, which participants in this trial may receive, has promising results for people with non-small cell lung cancer (NSCLC). In earlier studies, patients who took durvalumab after the usual treatment of chemotherapy and radiation lived longer without their cancer growing or spreading. This benefit lasted about 11 months longer than for those who did not take durvalumab. Additionally, the PACIFIC trial found that durvalumab helped patients live longer overall. These findings suggest that durvalumab could be an effective treatment for those with advanced NSCLC. ^{4 6 7 8 9}

Who Is on the Research Team?

Phillip Dennis, MD, PhD

Principal Investigator

AstraZeneca

Are You a Good Fit for This Trial?

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

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

You are expected to live for at least 12 more weeks.

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.

You currently have or have had a disease where your immune system attacks your own body, or a weak immune system.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinical-lung-cancer.com clinical-lung-cancer.com/article/S1525-7304(25)00154-8/fulltext

Real World Effectiveness of Durvalumab in Stage III ... Although not statistically significant, durvalumab-treated patients with PD-L1 TPS ≥ 1% experienced a modestly greater benefit in OS (2-year OS ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40075721/

Real-World Insights into the Impact of Durvalumab on ... The PACIFIC trial demonstrated that durvalumab after platinum-based chemoradiotherapy (CRT) improves overall survival (OS) and progression-free survival (PFS).

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1709937

Durvalumab after Chemoradiotherapy in Stage III Non– ... Among patients with locally advanced, unresectable NSCLC, progression-free survival was 11 months longer among patients who received durvalumab ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.21.01308

Five-Year Survival Outcomes From the PACIFIC Trial These updated analyses demonstrate robust and sustained OS and durable PFS benefit with durvalumab after chemoradiotherapy.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2819200

International Cost-Effectiveness Analysis of Durvalumab in ... This economic evaluation compares the cost-effectiveness of durvalumab for maintenance treatment of stage III non–small cell lung cancer ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40835220/

Long-Term Safety and Effectiveness of Durvalumab in ... Based on the PACIFIC trial results, durvalumab after chemoradiotherapy (CRT) is the standard of care for unresectable stage III NSCLC.

7. jto.org jto.org/article/S1556-0864(25)01014-7/fulltext

Long-Term Safety and Effectiveness of Durvalumab in ... This first and largest prospective, observational study demonstrated the long-term safety and effectiveness of durvalumab for unresectable stage ...

8. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00494-7/fulltext

A phase II clinical trial evaluating the safety and efficacy of ... Approximately 30–40% of patients with advanced and metastatic non-small cell lung cancer (NSCLC) present with an impaired performance status (PS).

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02087423

NCT02087423 | A Global Study to Assess the Effects of ... This study is designed to investigate the efficacy, safety, tolerability of a new drug, MEDI4736 (Durvalumab), in patients with Locally Advanced or ...