A trial to learn how safe newer immunotherapy drugs are and how well they work with or without other anti-cancer drugs in adults with advanced, unresectable non-small cell lung cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-06-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Efficacy, Others, Safety, Pharmacokinetic

To assess the safety and tolerability of immunotherapy with or without other anticancer drugs in participants with unresectable Stage III NSCLC

Secondary objectives 4

1. To demonstrate the efficacy of immunotherapy with or without other anticancer drugs by assessment of PFS in participants with unresectable Stage III NSCLC.
2. To demonstrate the efficacy of immunotherapy with or without other anticancer drugs by assessment of ORR for induction therapy or overall in participants with unresectable Stage III NSCLC.
3. To assess the PK of immunotherapy with or without other anticancer drugs.
4. To investigate the immunogenicity of immunotherapy, where relevant, with or without other anticancer drugs.

Conditions and MedDRA coding

Non-small Cell Lung Cancer

Regulatory references

Plan to share IPD

Yes

IPD plan description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 2. Histologically or cytologically documented squamous or non-squamous NSCLC.
2. 3. Unresectable stage III NSCLC eligible for concurrent chemoradiation. (Stage should be determined based on IASLC v9.0 Staging Guidelines; resectability should be determined by a multidisciplinary evaluation.)
3. 4. Documented absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) rearrangements.
4. 5. No known ROS1 or RET rearrangements detected as per local standard practice.
5. 6. Eligible for definitive, platinum-based cCRT to a total radiation dose of 60 Gy in 30 fractions using photons.
6. 7. ECOG performance status of 0 or 1.
7. 9. and 10. Known tumor PD-L1 "XXX" expression using documented local results with confirmed availablity of tumor tissue sample to confirm PD-L1 expression results.
8. 11. At least one lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT (preferred) or MRI, and is suitable for accurate repeated measurements.
9. 12. Adequate organ and bone marrow function.

Exclusion criteria 9

1. 1. Presence of small cell and/or neuroendocrine histology components; sarcomatoid variant; and/or other rare subtypes.
2. 2. Tumor invasion of the great vessels (aorta, superior/inferior vena cava, and/or intrapericardial vessels).
3. 3. Malignant pleural or pericardial effusion. Effusions must be assessed via thoracentesis or pericardiocentesis.
4. 5. History of idiopathic pulmonary fibrosis, ILD, non-infectious/radiation ILD/pneumonitis that required steroids or any active signs of these conditions that cannot be ruled out by imaging at screening. Additional exclusions include organizing pneumonia or drug-induced pneumonitis/ILD.
5. 7. History of organ transplant or allogeneic stem cell transplant.
6. 8. History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years prior to treatment assigment and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.
7. 12. Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment.
8. 13. Any prior or current systemic or radiation therapy received for NSCLC, or prior radiation therapy for any malignancy that included any lung tissue in the prior radiation fields.
9. 14. Prior exposure to an anti-PD-1, anti-PD-L1, or anti-TIGIT therapy, or any other anticancer therapy targeting immune regulatory receptors or mechanisms.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The safety and tolerability of immunotherapy with or without other anticancer drugs in participants with unresectable Stage III NSCLC will be assessed.

Secondary endpoints 4

1. PFS is defined as time from the date of treatment assignment/randomization or Cycle 1 Day 1 (as applicable, depending on the design of the relevant substudy) until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression).
2. ORR is defined as the proportion of participants who have a CR or PR, "XXX" per RECIST 1.1 for induction therapy or overall.
3. Concentration of immunotherapy in serum.
4. Presence of anti-drug antibodies (ADAs), positive or negative and titers

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

Clinical Study Information Center

Third parties 1

Locations

2 EU/EEA countries · 6 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications