A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients with Operable Non-Small Cell Lung Cancer (NSCLC)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Regeneron Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

11 Feb 2025 → ongoing

Decision date (initial)

2024-10-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Regeneron Pharmaceuticals Inc

External identifiers

EU CT number

2023-509806-31-00

ClinicalTrials.gov

NCT06465329

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy

To evaluate the antitumor activity of cemiplimab plus chemotherapy plus novel cancer treatments as compared to cemiplimab plus chemotherapy for the perioperative treatment of resectable NSCLC.

Secondary objectives 4

1. To evaluate the safety profile of cemiplimab plus chemotherapy plus novel cancer treatments as compared to cemiplimab plus chemotherapy.
2. To evaluate the feasibility of surgery in participants receiving cemiplimab plus chemotherapy plus novel cancer treatments as compared to cemiplimab plus chemotherapy.
3. To evaluate the immunogenicity of cemiplimab and novel anti-cancer agents in the investigational arms, and to evaluate the immunogenicity of cemiplimab in the control arm.
4. To evaluate the efficacy of cemiplimab plus chemotherapy plus novel cancer treatments as compared to cemiplimab plus chemotherapy.

Conditions and MedDRA coding

Non-Small Cell Lung Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
2. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
3. Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
4. Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
5. Adequate organ and bone marrow function, as described in the protocol
6. Note: Other protocol-defined Inclusion criteria apply.

Exclusion criteria 8

1. Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
2. Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) in the tumor prior to randomization, as described in the protocol
3. Presence of ≥ grade 2 peripheral neuropathy
4. Another malignancy that is progressing or requires active treatment, as described in the protocol Arm
5. Investigational arm 1 - Grade ≥3 hypercalcemia, as defined in the protocol
6. Investigational arm 1 - Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
7. Investigational arm 1 - Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram(QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol
8. Note: Other protocol-defined Exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR)

Secondary endpoints 21

1. Pathologic complete response (pCR) rate as determined by central BIPR
2. Residual viable tumor (RVT) as determined by central BIPR
3. Median event-free survival (EFS)
4. EFS rate
5. Objective response rate (ORR)
6. Overall survival (OS)
7. Incidence of treatment-emergent adverse events (TEAEs)
8. Severity of TEAEs
9. Incidence of TEAEs leading to death
10. Incidence of TEAEs leading to treatment discontinuation
11. Incidence of serious adverse events (SAEs)
12. Incidence of adverse events of special interest (AESIs)
13. Incidence of immune-mediated adverse events (imAEs)
14. Incidence of infusion-related reactions (IRRs)
15. Incidence of grade ≥3 laboratory abnormalities
16. Proportion of delayed surgeries due to TEAEs
17. Proportion of cancelled surgeries due to TEAEs
18. Incidence of anti-drug antibodies (ADAs) to cemiplimab over time
19. Titer of ADAs to cemiplimab over time
20. Incidence of ADAs to novel anti-cancer agents over time
21. Titer of ADAs to novel anti-cancer agents over time

Investigational products

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

Test 2

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Regeneron Pharmaceuticals Inc.

Sponsor organisation

Regeneron Pharmaceuticals Inc.

Address

777 Old Saw Mill River Road

City

Tarrytown

Postcode

10591-6717

Country

United States

Scientific contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Clinical Trial Information

Public contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Clinical Trial Information

Third parties 9

Locations

3 EU/EEA countries · 28 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 55 files

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

Application history

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