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

Phase 1

Conditions: 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]
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)

Registration Number: EUCTR2018-002932-26-PT

Lead Sponsor: MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC

Brief Summary: Not available

Detailed Description: Not available

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy<br>- Assess the antitumor activity of durvalumab alone and/or in combination with novel agents;Secondary Objective: Safety<br>- Assess the feasibility of receiving the planned surgical resection<br>- Assess the safety and tolerability of durvalumab alone and/or in combination with novel agents<br><br>Efficacy<br>- Assess the antitumor activity of durvalumab alone and/or in combination with novel agents<br><br>Pharmacokinetics<br>- To describe the PK of durvalumab alone and/or in combination with novel agents<br><br>Immunogenicity<br>(a) To assess the immunogenicity of durvalumab alone or in combination with novel agents<br>(b) To assess the immunogenicity of novel biologic agents in combination with durvalumab;Primary end point(s): Clinical activity<br>- Major Pathological Response (MPR) rate;Timepoint(s) of evaluation of this end point: MPR will be done in the resected specimen. Surgery is planned to take place within 14 days after the 4 weeks treatment period.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety<br>- Feasibility, defined as having the planned surgical resection within Day 29 to Day 42 after Week 1, Day 1<br>- Presence of AEs, SAEs, laboratory abnormalities, and vital signs<br><br>Efficacy<br>- Pathological Complete Response (pCR) rate<br><br>Pharmacokinetics<br>- Concentration of durvalumab or novel agents in plasma or serum<br><br>Immunogenicity<br>- ADA incidence of durvalumab or novel biologic agents;Timepoint(s) of evaluation of this end point: Safety<br>- Feasibility - Surgery is planned to take place within 14 days after the 4 weeks treatment period.<br>- AEs, SAEs, laboratory abnormalities, and vital signs - Up to 126 days after C1D1<br><br>Efficacy<br>- pCR will be done in the resected specimen. Surgery is planned to take place within 14 days after the 4 weeks treatment period.<br><br>Pharmacokinetics and Immunogenicity<br>- Up to 126 days after C1D1

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