Study of durvalumab or placebo administered after radiation therapy for patients with early stage non-small cell lung cancer

Phase 1

• Conditions: Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer; MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002572-41-IT
• Lead Sponsor: ASTRAZENECA AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-27
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 706

Inclusion Criteria

1. Age =18 years
2. Histologically or cytologically documented Stage I to II NSCLC, with clinical Stage I/II lymph node-negative (T1 to T3N0M0) disease and planned to receive definitive treatment with SBRT. Patients may be medically inoperable or are medically operable and refusing surgery or choosing to have SBRT (Stereotactic Body Radiation Therapy) as definitive therapy
3. Completion of SoC SBRT as definitive treatment prior to randomization
4. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) PS of 0, 1, or 2
5. Life expectancy of at least 12 weeks
6. Body weight >30 kg
7. Submission of available tumor tissue sample
8. Adequate organ and marrow function required
9. Patients with central or peripheral lesions are eligible
10. Staging studies must be done within 10 weeks before randomization
11. Pulmonary Function Testing within 12 weeks of randomization
12. Patients with a history of metachronus stage I/II (T1-T3N0M0) NSCLC treated definitively with radiation, surgery only, or surgery with adjuvant chemotherapy in whom all treatments completed >1 year prior to randomization are eligible.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 406

Exclusion Criteria

1. Mixed small cell and non-small cell cancer histology
2. History of allogeneic organ transplantation
3. History of another primary malignancy with exceptions
4. History of active primary immunodeficiency
5. Any unresolved toxicity National Cancer Institute (NCI) CTCAE Grade=2 from SBRT (Stereotactic Body Radiation Therapy)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified