Durvalumab + Chemotherapy for Small Cell Lung Cancer

(LUMINANCE Trial)

No longer recruiting at 48 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and tolerability of a treatment combination for people with extensive-stage small cell lung cancer (ES-SCLC). It examines the use of durvalumab (an immunotherapy) with chemotherapy drugs cisplatin or carboplatin, plus etoposide, as the initial treatment option. The trial targets individuals diagnosed with ES-SCLC who have not received previous immune-based therapies. Participants must be healthy enough to undergo chemotherapy and should not have active infections or recent treatments for other cancers. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

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

The trial does not specify if you need to stop taking your current medications, but you cannot take any other cancer treatments or immunosuppressive medications within 14 days before starting the trial. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that durvalumab is generally safe for lung cancer patients. Studies indicate it can be used after other treatments without causing unexpected side effects. One study confirmed its safety in patients with advanced lung cancer, comparing it to other treatments. The FDA has approved durvalumab for certain types of lung cancer, supporting its safety.

Carboplatin and cisplatin are both commonly used to treat lung cancer. Research has found that these drugs have similar safety profiles. Patients generally tolerate them well, with manageable side effects.

Etoposide is another drug used in this trial. Studies show that when combined with carboplatin or cisplatin, it is generally well-tolerated by patients with extensive-stage small cell lung cancer. Combining these drugs with immune therapies like durvalumab has shown promising safety results.

Overall, research supports that the combination of these treatments is mostly well-tolerated, with manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination treatment with Durvalumab for small cell lung cancer because it introduces an immunotherapy component to the traditional chemotherapy regimen. Unlike standard treatments that primarily use chemotherapy agents like cisplatin and etoposide alone, Durvalumab is an immune checkpoint inhibitor that helps the body’s immune system recognize and attack cancer cells. This approach is promising because it not only targets the cancer directly through chemotherapy but also enhances the body’s natural defenses to fight the cancer, potentially leading to better outcomes for patients.

What evidence suggests that this trial's treatments could be effective for small cell lung cancer?

Research has shown that combining the drug durvalumab with chemotherapy medicines like cisplatin or carboplatin and etoposide effectively treats extensive-stage small-cell lung cancer (ES-SCLC). The CASPIAN study demonstrated that this combination helped patients live longer than chemotherapy alone. This treatment is now approved as the first choice for ES-SCLC and has shown promising results in previous patients. Overall, evidence supports that this treatment can improve survival for people with this type of lung cancer. Participants in this trial will receive durvalumab combined with either cisplatin or carboplatin and etoposide. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06419179?term=olaparib&cond=Lung%20Cancer&viewType=Table&rank=1

Study Details | NCT06419179 | Maintenance Durvalumab ... Study treatment ( olaparib and durvalumab) starts with the initiation of maintenance therapy and is administered at a 28-day cycle until progression, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12270619/

Platinum plus etoposide with durvalumab for extensive-stage ... Forthcoming phase II study of durvalumab (MEDI4736) plus chemotherapy for small cell lung cancer with brain metastases. Cancer Manag Res.

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04472949?term=NCT04472949&draw=2&rank=1

NCT04472949 | Thoracic Radiotherapy Plus Maintenance ... The trial SAKK 15/19 is investigating whether thoracic radiotherapy and the administration of durvalumab can slow down the progression of the disease. In ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S246829422500108X

First-line durvalumab plus platinum–etoposide in ... Given the efficacy observed in the CASPIAN study, the combination of durvalumab with EP chemotherapy has received approval as a first-line therapy for ES-SCLC ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8134304/

First-line durvalumab plus platinum-etoposide in extensive ... In the phase 3 CASPIAN study (NCT03043872), first-line durvalumab plus etoposide and cisplatin or carboplatin (EP) significantly improved OS versus EP alone ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0959804925006288

Survival outcomes with carboplatin versus cisplatin and the ... During the pandemic, quarterly usage rates of carboplatin reached up to 81% and 90% in LS-SCLC and ES-SCLC, respectively. In LS-SCLC, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12206876/

Real-world safety of carboplatin in non-small cell lung cancer This study aims to systematically assess carboplatin-related AEs and explore demographic factors that may influence risk.

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.8525

Safety and efficacy of QL1706 plus carboplatin/etoposide ... QL1706 plus EC chemotherapy showed tolerable safety profile and promising efficacy as first-line treatment for pts with ES-SCLC.

9. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)36078-8/fulltext

Safety and patient-reported outcomes of atezolizumab, ... The addition of atezolizumab to carboplatin and etoposide (CP/ET) significantly improved progression-free and overall survival for patients with ...

10. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2797497

Comparison of Carboplatin With Cisplatin in Small Cell ... For 2652 patients with extensive-stage SCLC, the median OS was 8.45 months for cisplatin and 8.51 months for carboplatin, and for 1756 patients ...