A trial to learn how safe different combinations of anti-cancer drugs are and how well they work in adults with advanced or metastatic non-small cell lung cancer (NSCLC)

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)

2026-05-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

External identifiers

EU CT number

2025-524843-11-00

ClinicalTrials.gov

NCT07098338

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Pharmacokinetic, Safety

To assess the safety and tolerability and determine the recommended dose of the combination of novel anti-cancer agents
To assess the efficacy of novel agents in combination with other anti-cancer agents by evaluation of ORR

Secondary objectives 3

1. To further assess the efficacy of novel agents in combination with other anti-cancer agents by evaluation of tumour response and OS
2. To assess the PK profile of study interventions in participants receiving treatment
3. To assess the immunogenicity of study interventions in participants receiving treatment

Conditions and MedDRA coding

Non-Small Cell Lung Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Participant must be ≥ 18 years of age at the time of signing the ICF
2. WHO/ECOG performance status of 0 or 1
3. At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
4. Adequate bone marrow and organ function
5. Life expectancy ≥ 12 weeks
6. Provision of acceptable tumour tissue
7. Specific for Sub-Study 1 and Sub-Study 2: Histologically or cytologically documented advanced or metastatic NSCLC
8. Specific for Sub-Study 1 and Sub-Study 2: PD-L1 TC ≥ 1% (TC≥ 50% for sub-study 1, 1-49% for sub-study 2)
9. Specific for Sub-Study 1 and Sub-Study 2: Absence of sensitizing EGFR mutations or ALK rearrangements. No known other Actionable Genomic Alterations(AGAs)

Exclusion criteria 13

1. As judged by the investigator, any severe or uncontrolled systemic diseases, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol
2. Active or prior documented autoimmune or inflammatory disorders
3. Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia.
4. Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study 2.
5. Unstable brain metastases
6. History of another primary malignancy.
7. Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV.
8. Uncontrolled or significant cardiac disease
9. Receipt of prior systemic chemotherapy/chemoradiation/immunotherapy for advanced NSCLC for sub-study 1 and sub-study 2.
10. Prior exposure to immune-mediated therapy
11. History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation
12. Any concurrent anti-cancer treatment.
13. Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Number of participants with adverse events (AE) and serious adverse events (SAE)
2. Objective response rate (ORR)

Secondary endpoints 9

1. Best Overall Response(BOR)
2. Change in Target Lesion Tumor Size
3. Progression free survival (PFS)
4. Disease Control Rate(DCR) at 12 Weeks
5. Duration Of Response (DoR)
6. Overall Survival(OS)
7. Serum concentration
8. Maximum plasma drug concentration (Cmax)
9. Immunogenicity of study interventions in participants receiving treatment

Investigational products

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

Test 2

Auxiliary 2

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

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Third parties 1

Locations

3 EU/EEA countries · 18 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 33 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