eoadjuvant Durvalumab Alone or in Combination with Novel Agents in Resectable Non-Small Cell Lung Cancer

Phase 1

• Conditions: Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer; MedDRA version: 20.0Level: PTClassification code 10029517Term: Non-small cell lung cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10029518Term: Non-small cell lung cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.1Level: PTClassification code 10029520Term: Non-small cell lung cancer stage IIIASystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002932-26-ES
• Lead Sponsor: MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-27
• Study Completion: 2021-01-13
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Cytologically and/or histologically-documented NSCLC
(a) Stage I (> 2 cm) to IIIA (For subjects with N2 disease, only those with 1 single nodal station <= 3 cm are eligible) NSCLC
(b) Amenable to complete surgical resection
(c) Have not received any other therapy for this condition
2. Age >=18 years old
3. Predicted FEV1 >== 50%
4. Predicted DLCO = 50%
5. ECOG 0 or 1
6. Adequate organ function
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 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

1. Subjects with small-cell lung cancer or mixed small-cell lung cancer
2. Subjects who require or may require pneumonectomy
3. Prior treatment with PD-L1, PD-L1, or CTLA-4 inhibitors
4. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug.
5. Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion:
a. Subjects with vitiligo or alopecia
b. Subjects with hypothyroidism on hormone replacement
c. Any chronic skin condition that does not require systemic therapy
d. Subjects without active disease in the last 5 years may be included but only after consultation with the study physician
e. Subjects with celiac disease controlled by diet alone
6. Pregnant or breast-feeding female
7. Major surgical procedure within prior 30 days
8. History of active primary immunodeficiency
9. Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV
10. QTc interval (QTc) >= 470 ms
11. Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent
12. Receipt of live attenuated vaccination within 30 days prior to study entry
13. History of another primary malignancy except for:
a. Curative-treated malignancy with no known active disease > 2 years before enrollment on the study
b. Curative-treated non-melanoma skin cancer and/or carcinoma in-situ

Study & Design

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