Trial NCT07149363
Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer
- Phase
- Phase 2
- Sponsor
- Alliance Foundation Trials, LLC.
- Conditions
- Small Cell Lung Cancer (SCLC)
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Performance status
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:Prior malignancy
* 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.
Restrictions found (2)
- Performance statusOutrightinclusion
ECOG 0-1
Show in the text - Prior malignancyConditionalexclusionShow in the text
Recruiting in Massachusetts
- Massachusetts General Hospital (MGH) · Boston, Suffolk County
- Dana Farber Cancer Institute · Boston, Suffolk County