Durvalumab + Chemotherapy for Small Cell Lung Cancer

(LUMINANCE Trial)

Recruiting at 36 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must be taking: Platinum chemotherapy

Must not be taking: Immunosuppressants, Immunotherapy

Disqualifiers: Autoimmune disorders, Active infection, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2.5 years

152 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a combination of durvalumab and chemotherapy drugs (cisplatin or carboplatin, and etoposide) in patients with extensive-stage small-cell lung cancer. Durvalumab helps the immune system fight cancer, while the chemotherapy drugs kill cancer cells. The goal is to see if this combination is safe and can be tolerated by patients. Durvalumab has been shown to improve overall survival when combined with chemotherapy in extensive-stage small-cell lung cancer (SCLC).

Eligibility Criteria

This trial is for adults with extensive-stage small cell lung cancer who haven't had treatment before. They should be in good physical condition, have proper organ function, and weigh over 30 kg. Women must not be pregnant and participants must agree to use birth control. People can't join if they've had certain vaccines recently, previous cancer treatments for SCLC, or are on immunosuppressants.

Inclusion Criteria

I have not been treated with immune therapy drugs before.

I am eligible for a first-time chemotherapy that includes platinum for my small cell lung cancer.

My small cell lung cancer is confirmed by tests and is at an advanced stage.

Exclusion Criteria

I have had treatment for small cell lung cancer that has spread.

I do not have active infections like TB, hepatitis B, C, or HIV.

I have or had lupus, sarcoidosis, or wegener syndrome.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive durvalumab in combination with platinum-based chemotherapy and etoposide every 3 weeks, followed by durvalumab monotherapy every 4 weeks

Up to 2.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days after treatment discontinuation

Treatment Details

Interventions

• Carboplatin
• Cisplatin
• Durvalumab
• Etoposide

Trial Overview The study tests the safety of Durvalumab combined with platinum (either Cisplatin or Carboplatin) plus Etoposide as a first-line treatment for patients with extensive-stage small cell lung cancer. It aims to see how well patients tolerate this combination therapy.

Participant Groups

Group I: Durvalumab - (cisplatin or carboplatin) - Etoposide Experimental Treatment 4 Interventions

Participants will receive durvalumab dose A administered via intravenous (IV) infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w). Thereafter, durvalumab monotherapy will be continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria are met.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

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