Authorised Therapeutic confirmatory (Phase III) Patients with Limited Stage Small-Cell Lung Cancer (LS-SCLC)

Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

EU CTIS ID: 2023-509602-29-00

What this study is testing

To assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS To assess the efficacy of durvalumab monotherapy compared to placebo in terms of OS

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Histologically or cytologically documented limited-stage SCLC (Stage I-III SCLC any, N any, i.e., patients whose disease can be encompassed within a radical radiation portal - Patients with Stage I to IIA disease must be medically inoperable as determined by investigator. Received an appropriate first line concurrent chemoradiotherapy regimen as defined below, unless after consultation with the global study medical team an alternative is acceptable, received 4 cycles of platinum-based chemotherapy concurrent with RT, which must be completed within 1 to 42 days prior to first dose of IP. The chemotherapy regimen must contain platinum and IV etoposide administered, as per local standard-of-care regimens. The radiotherapy must have commenced no later than the end of Cycle 2 of chemotherapy and patients must have received a total dose of radiation of 60 to 66 Gy over 6 weeks for standard QD radiation schedules or 45 Gy over 3 weeks for hyperfractionated BID radiation schedules. Patients must have achieved CR, PR, or SD and not have progressed following definitive, platinum-based chemotherapy, concurrent with RT. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment and randomization. Mandatory availability of tumor sample, which may include a core needle biopsy, newly cut unstained slides, or fine needle aspirate (FNA) cell block samples. Tissue sample should be submitted before or within 60 days of randomization. However, patients may be enrolled into the study before the pre-treatment tumor tissue sample is submitted. A newly acquired tumor biopsy (taken following completion of chemoradiotherapy) is optional, provided that a biopsy procedure is technically feasible, and the procedure is not associated with unacceptable clinical risk. PCI may be delivered at the discretion of investigator and per local standard of care, and completion within 42 days of completion of concurrent CRT.

You likely can't join if

  • Extensive-stage SCLC. Mixed SCLC and NSCLC histology. Brain metastases or spinal cord compression. All patients will have an MRI (preferred) or CT, preferably with IV contrast of the brain, after completion of first line concurrent chemoradiotherapy and within 1 to 42 days prior to randomization and the first dose of IP. Patients who received sequential chemoradiation therapy for LS-SCLC (no overlap of RT with chemotherapy). Receipt of chemotherapy that exceeds 4 cycles in total. Chemotherapy regimens other than etoposide and platinum are not permitted. Any history of Grade ≥2 pneumonitis Active or prior documented autoimmune/inflammatory disorders, uncontrolled intercurrent illness or active infections Prior exposure to immune-mediated therapy.

The study team makes the final eligibility decision.

Where it's taking place

  • Russian Federation
  • Taiwan
  • India
  • Turkey
  • United Kingdom
  • Korea, Republic of
  • Argentina
  • China
  • Japan
  • United States
  • Vietnam
  • Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Russian Federation; Taiwan; India; Turkey; United Kingdom; Korea, Republic of and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.