NCT03116971 is a Phase 1 clinical trial of M3814 in Small Cell Lung Cancer, sponsored by EMD Serono Research & Development Institute, Inc..

Who is sponsoring NCT03116971?

NCT03116971 is sponsored by EMD Serono Research & Development Institute, Inc..

What drugs are being tested in NCT03116971?

Interventions in NCT03116971: M3814, Cisplatin, Etoposide.

What condition does NCT03116971 study?

NCT03116971 studies Small Cell Lung Cancer.

Is NCT03116971 still recruiting?

NCT03116971 is currently terminated. Last updated 16 September 2020.

Last reviewed 2020-09-16 · How we verify

NCT03116971

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

Phase Ib/II Study of M3814 With Etoposide and Cisplatin in Small Cell Lung Cancer (SCLC) Extensive Disease (ED)

Terminated Phase 1 Last updated 16 September 2020

What this trial tests

Phase 1 trial testing M3814 in Small Cell Lung Cancer in 2 participants. Terminated before completion.

Timeline

25 May 2017

Primary endpoint
1 March 2018

1 March 2018

Quick facts

Lead sponsor	EMD Serono Research & Development Institute, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	2
Start date	25 May 2017
Primary completion	1 March 2018
Estimated completion	1 March 2018
Sites	80 locations across Denmark, Italy, Belgium, United Kingdom, Germany, Hungary, Poland, Romania

Drugs / interventions tested

M3814 — full drug profile →
Cisplatin (cisplatin) — full drug profile →
Etoposide (etoposide) — full drug profile →

Conditions studied

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

Sponsor

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

Who can join

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

Sponsor's own description

M3814 is an investigational drug under evaluation for treatment of lung cancer. The purpose of the study was to assess the Safety and Efficacy of M3814 in combination with chemotherapy with SCLC ED.

Publications & conference data

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

Simultaneous precise editing of multiple genes in human cells.
Riesenberg S, Chintalapati M, Macak D, Kanis P, et al · · 2019 · cited 101× · PMID 31392986 · DOI 10.1093/nar/gkz669
Advance trends in targeting homology-directed repair for accurate gene editing: An inclusive review of small molecules and modified CRISPR-Cas9 systems.
Shams F, Bayat H, Mohammadian O, Mahboudi S, et al · · 2022 · cited 31× · PMID 35975201 · DOI 10.34172/bi.2022.23871
Exploiting DNA Damage Repair in Precision Cancer Therapy: BRCA1 as a Prime Therapeutic Target.
Raimundo L, Calheiros J, Saraiva L. · · 2021 · cited 23× · PMID 34298653 · DOI 10.3390/cancers13143438
DNA-PK inhibition extends the therapeutic effects of Top2 poisoning to non-proliferating cells, increasing activity at a cost.
Wang T, Kyle AH, Baker JHE, Liu NA, et al · · 2023 · cited 4× · PMID 37528151 · DOI 10.1038/s41598-023-39649-7
DNA-dependent protein kinase inhibitor as a sensitizer of radiotherapy in locally advanced rectal cancer.
Kagawa Y, Watanabe J, Ando K. · · 2024 · cited 1× · PMID 39554583 · DOI 10.21037/jgo-24-373
Strategies to Target Chemoradiotherapy Resistance in Small Cell Lung Cancer.
Yu T, Lok BH. · · 2024 · PMID 39456533 · DOI 10.3390/cancers16203438

Verify or expand the search:

Other trials of M3814

Trials testing the same drug.

NCT03724890 — Study of Avelumab-M3814 Combinations · Phase 1 · completed

Other recruiting trials for Small Cell Lung Cancer

Currently open trials in the same condition.

NCT07476287 — Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult · Phase 2 · recruiting
NCT07296809 — SKB500 Combinations in Patients With Small Cell Lung Cancer · Phase 2 · recruiting
NCT07155200 — Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial) · Phase 1, PHASE2 · recruiting
NCT06922539 — ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer · Phase 1 · recruiting
NCT07373964 — A Prospective, Single-Arm, Single-Center Phase II Study Evaluating the Efficacy and Safety of Chidamide Combined With PD · Phase 2 · 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 NCT03116971 (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: 16 September 2020

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/NCT03116971.

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