NCT05882734 is a Phase 1, PHASE2 clinical trial of M1774 in Non-Small Cell Lung Cancer, sponsored by EMD Serono Research & Development Institute, Inc..

Who is sponsoring NCT05882734?

NCT05882734 is sponsored by EMD Serono Research & Development Institute, Inc..

What drugs are being tested in NCT05882734?

Interventions in NCT05882734: M1774, Cemiplimab.

What condition does NCT05882734 study?

NCT05882734 studies Non-Small Cell Lung Cancer.

Is NCT05882734 still recruiting?

NCT05882734 is currently active, enrolled. Last updated 17 February 2026.

Last reviewed 2026-02-17 · How we verify

NCT05882734

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)

Active, enrolled Phase 1, PHASE2 Last updated 17 February 2026

What this trial tests

Phase 1, PHASE2 trial testing M1774 in Non-Small Cell Lung Cancer in 61 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 September 2023

Primary endpoint
30 March 2026

30 March 2026

Quick facts

Lead sponsor	EMD Serono Research & Development Institute, Inc.
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	13 September 2023
Primary completion	30 March 2026
Estimated completion	30 March 2026
Sites	54 locations across France, Italy, Japan, Belgium, Germany, South Korea, United States, Spain

Drugs / interventions tested

M1774 — full drug profile →
Cemiplimab (CEMIPLIMAB) — full drug profile →

Conditions studied

Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →

Sponsor

EMD Serono Research & Development Institute, Inc. — full company profile →

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an Open-label, multicenter clinical study conducted in two Phases to establish the efficacy, safety, tolerability, and pharmacokinetics of the ataxia telangiectasia mutated and Rad3-related protein kinase (ATR) inhibitor Tuvusertib in Combination with Cemiplimab in Participants with Non-Squamous Non-Small Cell Lung Cancer (nsqNSCLC) that has Progressed on Prior Anti-PD-(L)1 and Platinum-based Therapies..

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

DNA repair and the contribution to chemotherapy resistance.
Nesic K, Parker P, Swisher EM, Krais JJ. · · 2025 · cited 16× · PMID 40420317 · DOI 10.1186/s13073-025-01488-8
Advancing cancer therapy: new frontiers in targeting DNA damage response.
Qian J, Liao G, Chen M, Peng RW, et al · · 2024 · cited 16× · PMID 39372203 · DOI 10.3389/fphar.2024.1474337
Targeting the DNA damage response in cancer.
Federica G, Michela C, Giovanna D. · · 2024 · cited 12× · PMID 39492835 · DOI 10.1002/mco2.788
Role of the TME in immune checkpoint blockade resistance of non-small cell lung cancer.
Dai Y, Tian X, Ye X, Gong Y, et al · · 2024 · cited 11× · PMID 39802954 · DOI 10.20517/cdr.2024.166
Clinical translation for targeting DNA damage repair in non-small cell lung cancer: a review.
Mao X, Lee NK, Saad SE, Fong IL. · · 2024 · cited 11× · PMID 38496700 · DOI 10.21037/tlcr-23-742
Cancer Vulnerabilities Through Targeting the ATR/Chk1 and ATM/Chk2 Axes in the Context of DNA Damage.
Fernandez A, Artola M, Leon S, Otegui N, et al · · 2025 · cited 9× · PMID 40422251 · DOI 10.3390/cells14100748
Genome instability and crosstalk with the immune response.
Chabanon RM, Danlos FX, Ouali K, Postel-Vinay S. · · 2025 · cited 4× · PMID 41188872 · DOI 10.1186/s13073-025-01509-6
The interplay of DNA damage, epigenetics and tumour heterogeneity in driving cancer cell fitness.
Rouault CD, Charafe-Jauffret E, Ginestier C. · · 2025 · cited 3× · PMID 41028732 · DOI 10.1038/s41467-025-64445-4

Verify or expand the search:

Other trials of M1774

Trials testing the same drug.

NCT06518564 — Avelumab and M1774 in ARID1A-mutated Endometrial Cancer · Phase 2 · recruiting
NCT05986071 — I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers · Phase 1, PHASE2 · not yet recruiting
NCT04170153 — Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 3 · Phase 1 · active not recruiting

Other recruiting trials for Non-Small Cell Lung Cancer

Currently open trials in the same condition.

NCT07140315 — DK222 Study at Hopkins · Phase 1 · recruiting
NCT07487883 — Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors · recruiting
NCT07413757 — CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC · recruiting
NCT07460999 — Singing Training vs Usual Care 6-18 Months After Surgical Resection for Non-small Cell Lung Cancer (NSCLC) · NA · recruiting
NCT07479277 — Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC · NA · recruiting

Other EMD Serono Research & Development Institute, Inc. trials

Trials by the same sponsor.

NCT07355218 — A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2) · Phase 3 · recruiting
NCT07332481 — A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease · Phase 3 · recruiting
NCT07360314 — Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07166601 — M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid · Phase 1 · recruiting
NCT07097259 — A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05882734 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by EMD Serono Research & Development Institute, Inc.
Last refreshed: 17 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05882734.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing