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Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment65 people
  • Recruiting US sites6
  • SponsorAlliance Foundation Trials, LLC.
  • RegistryNCT07149363

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer: a one-minute explainerNCT071493631 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • Age ≥ 18 years.
  • Body weight >30 kg.
  • Must have a life expectancy of at least 12 weeks.
  • Must have histologically or cytologically confirmed diagnosis of pathologic T1-T2 N0-1 M0 small-cell lung cancer per the American Joint Committee on Cancer staging system, 8th edition.
  • Have completely resected (wedge resection, segmentectomy, lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy) small-cell lung cancer within 78 days of enrollment.
  • Complete mediastinal lymph node dissection (MLND) or systematic mediastinal lymph node sampling is required.
  • No prior systemic therapies, for small cell lung cancer.
  • Post-operative radiation for the resected small cell lung cancer is acceptable per treating physician in the setting of N1 disease, but no other prior radiation for small cell lung cancer.
  • ECOG performance status 0-1.

You cannot join if

  • Patients who are receiving any other investigational agents.
  • Concurrent enrollment in another clinical study involving investigational treatment directed to treatment of patients with small cell lung cancer.
  • Prior treatment with durvalumab.
  • History of another primary malignancy except for:
  • Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • Superficial bladder cancer without active disease after treatment.
  • Low grade prostate cancer without indication for active treatment.
  • Adequately treated carcinoma in situ without evidence of disease.
  • Patients with a history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 3 months.
  • Patients with hemoptysis in excess of 2.5 mL within 2 weeks prior to the first dose of study medication.
  • Patients requiring concomitant therapy with phenytoin, phenobarbital, or carbamazepine.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

durvalumab. A monoclonal antibody directed against B7H1 (B7 homolog 1; programmed cell death ligand 1) with potential immunostimulating activity. Upon intravenous administration, durvalumab binds to the cell surface antigen B7H1, thereby blocking B7H1 signaling. This may activate the immune system to exert a cytotoxic T-lymphocyte (CTL) response against B7H1-expressing tumor cells. B7H1, a member of the B7 protein superfamily and a negative regulator of cytokine synthesis, is overexpressed on certain tumor cell types. NCI Drug Dictionary

Treatments listed in the registry

  • Durvalumab 50 MG/ML (Drug): Following surgical removal of their small-cell lung cancer, participants will receive a combination of 1500 mg durvalumab and cisplatin 75 mg/m2 or carboplatin AUC 5 on day 1, and etoposide 100 mg/m2 on days 1, 2, and 3, every 3 weeks for 4 cycles (a total of 12 weeks). Following the combination of chemotherapy and immunotherapy, participants will then receive 1500 mg durvalumab every 4 weeks for 9 cycles (a total of 36 weeks).

The study

Treatment groups

Na · Single Group · masking: None

Durvalumab and one of the two chemotherapy combinations: cisplatin or carboplatin, and etoposide (Experimental)

65 participants will be enrolled.

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • surgery: Part of the study plan

Goals

What the study measures

Main goals

  • Disease free survival (DFS) (2 years)

Other goals

  • Overall survival (OS)
  • Safety of the regimen
  • Safety of the regimen

Planned enrollment: 65 (estimated).

Where

Recruiting US sites

  • University of Illinois Chicago, Chicago, Illinois
  • Maine Medical Center, Scarborough, Maine
  • Massachusetts General Hospital (MGH), Boston, Massachusetts
  • Dana Farber Cancer Institute, Boston, Massachusetts
  • Washington University in St. Louis School of Medicine, St Louis, Missouri
  • University of Virginia Comprehensive Cancer Center, Charlottesville, Virginia

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 14, 2026. Public record; not medical advice.

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