MK-6070 and I-DXd in Relapsed/Refractory Small Cell Lung Cancer

• Research type

  Research Study

• Full title

  A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer

• IRAS ID

  1012309

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06780137

• Research summary

  Researchers are looking for new ways to treat participants with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory.

  The first treatment for SCLC is chemotherapy and immunotherapy. Researchers want to know if giving MK-6070 alone, ifinatamab deruxtecan (I-DXd) alone, and MK-6070 with I-DXd or durvalumab can treat SCLC. MK-6070 is a type of immunotherapy. I-DXd is an antibody drug conjugate. Durvalumab is a different type of immunotherapy.

  The goals of this trial are to learn if:
  • MK-6070 alone, I-DXd alone, and MK-6070 with I-DXd or durvalumab are safe and if they are tolerated
  • SCLC responds in participants who receive MK-6070 alone, I-DXd alone, and MK-6070 with I-DXd or durvalumab

  About 242 participants with SCLC will be in this trial. They will be at least 18 years old and:
  • Have been previously treated with chemotherapy with or without immunotherapy
  • Have a tumour sample available for testing.
  • Don’t have certain lung or heart problems

  Participants will receive 1 or 2 of these treatments:
  • MK-6070
  • I-DXd
  • Durvalumab

  Participants will receive MK-6070 and I-DXd every 2 or 3 weeks and durvalumab every 4 weeks. MK-6070, I-DXd, and durvalumab are given by a needle in a vein.

  This trial has 3 parts. The UK is only taking part in Parts 2 and 3. Researchers will test different dose amounts and schedules for treatments, will check for safety concerns and, if needed, lower doses.

  Participants who receive MK-6070 may stay in the hospital for different lengths of time during the trial.

  Both the participants and researchers will know which trial treatment a person is getting. Participants may give urine, blood, and tumour samples during the trial, have imaging tests, eye tests, physical examinations, and tests to check their heart. Participants may be in this trial for up to 5 years.

• REC name

  Wales REC 2

• REC reference

  25/WA/0282

• Date of REC Opinion

  4 Dec 2025

• REC opinion

  Further Information Favourable Opinion