RightFit
RecruitingPhase 2

Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This phase II study tests chemotherapy and immunotherapy after surgery to remove all small cell lung cancer. Chemotherapy kills cancer cells, and immunotherapy helps the immune system fight cancer. The study is for adults whose cancer was fully removed by surgery.

This is a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and weigh more than 30 kg (about 66 pounds).
  • Be expected to live at least 12 weeks.
  • Have small cell lung cancer confirmed by tissue or cell tests, at stage T1–T2 N0–1 M0. This means limited tumor growth, with no spread to distant parts of the body.
  • Have had surgery to remove all the lung cancer within 78 days before joining.
  • Have had lymph nodes in the middle of the chest removed or sampled to check for cancer.
  • Have had no drug treatments that travel through the body to treat small cell lung cancer.
  • Have had no radiation for small cell lung cancer, except radiation after surgery for N1 disease (cancer in nearby lymph nodes), if approved by the treating doctor.
  • Be fully active or able to do light work despite limits on hard physical activity.

Who can't join

  • Be receiving another experimental drug.
  • Be enrolled in another study of an experimental treatment for small cell lung cancer.
  • Have been treated with durvalumab before.
  • Have a history of another cancer. Exceptions include cancer treated to cure it, with no active disease for at least 2 years and a low risk of return; certain treated skin cancers; treated surface-level bladder cancer; low-grade prostate cancer not needing active treatment; or treated cancer that had not spread beyond where it started.
  • Have had a stroke, mini-stroke, blood clot in the lungs, or a deep-vein blood clot that was not treated enough within the past 3 months.
  • Have coughed up more than 2.5 mL (about half a teaspoon) of blood within 2 weeks before the first study dose.
  • Need to take phenytoin, phenobarbital, or carbamazepine during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Study sites (6)

IL

MA

ME

MO

VA