New drug combo aims to outperform standard care in aggressive lung cancer

NCT ID NCT07625644

Disease control Sponsor: SystImmune Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 6 times

Summary

This Phase 3 trial will test whether a new drug called BL-M14D1 combined with atezolizumab works better than the current standard treatment for people with extensive-stage small cell lung cancer who have not had prior therapy. About 550 adults will be randomly assigned to receive either the experimental combination or standard care. The main goal is to see if the new combination delays cancer progression or improves survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: BL-M14D1 and atezolizumab (drug combination)
What this could lead to: If successful, this could offer a new first-line treatment option for extensive-stage small cell lung cancer, potentially improving how long patients live without their cancer growing.
What could go wrong: This is an early-stage trial (Phase 3) and the experimental drug combination may not work better than current standard care. Side effects from the new drug combination are unknown and could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 550 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically or cytologically confirmed first-line (1L), extensive-stage (ES) small cell lung cancer (SCLC) * Must be eligible to receive a platinum-based chemotherapy regimen in combination with an anti-PD-L1 inhibitor. * At least one measurable lesion based on RECIST v1.1 per investigator assessment. * An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1. * Adequate organ function Exclusion Criteria: * Received any kind of platinum or etoposide treatment for limited stage (LS) SCLC within 6 months prior to enrollment. * Participants who have received prior topoisomerase inhibitor-based ADC therapy. * Participants with history of severe heart disease * Participants with active autoimmune diseases and inflammatory diseases, * Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years * Other protocol-defined inclusion/exclusion criteria apply.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm metastatic malignant neoplasm small cell carcinoma small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung cancer Lung cancer metastatic Lung cancer stage IV SCLC SCLC,extensive stage Small cell carcinoma Small cell lung cancer Small cell lung cancer extensive stage

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

62 sites in 14 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AOUS Le Scotte, UOC Immunoterapia Oncologica
NOT_YET_RECRUITING

Siena, 53100, Italy
Arthur Child Cancer Centre
NOT_YET_RECRUITING

Calgary, Alberta, T2N 5G2, Canada
Astera Cancer Care
RECRUITING

East Brunswick, New Jersey, 08816, United States
Bács-Kiskun Vármegyei Oktatókórház, Oncoradiology Center
NOT_YET_RECRUITING

Kecskemét, 6000, Hungary
CLB - Centre Léon Bérard
NOT_YET_RECRUITING

Lyon, 69008, France
Canberra Hospital
NOT_YET_RECRUITING

Garran, Australian Capital Territory, 2605, Australia
Caucasus Medical Centre
NOT_YET_RECRUITING

Tbilisi, 0186, Georgia
Centro de Investigación Oncológica Clara Campal
NOT_YET_RECRUITING

Madrid, 28050, Spain
Centro di Riferimento Oncologico
NOT_YET_RECRUITING

Aviano, 33081, Italy
Complejo Hospitalario Universitario A Coruna (CHUAC) - Hospital Teresa Herrera
NOT_YET_RECRUITING

A Coruña, 15006, Spain
European Interbalkan Medical Center
NOT_YET_RECRUITING

Thessaloniki, 57001, Greece
Fakultní nemocnice Ostrava (FN Ostrava)
NOT_YET_RECRUITING

Ostrava-Poruba, 708 52, Czechia
Flinders Medical Centre
NOT_YET_RECRUITING

Bedford Park, South Australia, 5042, Australia
Fondazione Policlinico Universitario A. Gemelli IRCCS
NOT_YET_RECRUITING

Roma, 00168, Italy
Henry Dunant Hospital Center
NOT_YET_RECRUITING

Athens, 11526, Greece
Highlands Oncology Group
NOT_YET_RECRUITING

Springdale, Arkansas, 72762, United States
Hospital Clinico San Carlos
NOT_YET_RECRUITING

Madrid, 28040, Spain
Hospital Universitario Insular de Gran Canaria
NOT_YET_RECRUITING

Las Palmas de Gran Canaria, 35016, Spain
Hospital de la Santa Creu i Sant Pau
NOT_YET_RECRUITING

Barcelona, 08041, Spain
ICO - L'Institut de Cancérologie de L'Ouest
NOT_YET_RECRUITING

Saint-Herblain, 44805, France
IPC - lnstitut Paoli-Calmettes
NOT_YET_RECRUITING

Marseille, 13273, France
Institute for pulmonary diseases of Vojvodina
NOT_YET_RECRUITING

Novi Sad, 21208, Serbia
Instytut "Centrum Zdrowia Matki Polki", Klinika Onkologii
NOT_YET_RECRUITING

Lodz, 93-338, Poland
KEM | Evangelische Kliniken Essen Mitte gGmbH
NOT_YET_RECRUITING

Essen, 45136, Germany
Krankenhaus Martha-Maria Halle-Dölau
NOT_YET_RECRUITING

Halle, 06120, Germany
LLC Todua Clinic
NOT_YET_RECRUITING

Tbilisi, 0119, Georgia
LTD High Technology Hospital Medcenter
NOT_YET_RECRUITING

Tbilisi, 0114, Georgia
Los Alamitos Hematology/Oncology Medical Group
RECRUITING

Glendale, California, 91203, United States
Ltd New Hospitals
NOT_YET_RECRUITING

Tbilisi, 0114, Georgia
Lungenklinik/Lungenkrebszentrum Köln-Merheim
NOT_YET_RECRUITING

Cologne, 51109, Germany
MHAT Dr. Tota Venkova
NOT_YET_RECRUITING

Gabrovo, 5300, Bulgaria
MHAT Heart and Brain
NOT_YET_RECRUITING

Pleven, 5800, Bulgaria
MHAT Pulmed
NOT_YET_RECRUITING

Plovdiv, 4002, Bulgaria
MHAT Serdikamed
NOT_YET_RECRUITING

Sofia, 1632, Bulgaria
Medical Centre FutureMeds
NOT_YET_RECRUITING

Plovdiv, 1431, Bulgaria
MemorialCare Todd Cancer Institute
RECRUITING

Long Beach, California, 90806, United States
Mátrai Gyógyintézet
NOT_YET_RECRUITING

Gyöngyös, 7151, Hungary
Nemocnice Agel Vítkovice
NOT_YET_RECRUITING

Ostrava, 703 00, Czechia
Nemocnice České Budějovice, a.s.
NOT_YET_RECRUITING

České Budějovice, 370 01, Czechia
Oddzial Onkologii Klinicznej
NOT_YET_RECRUITING

Katowice, 40-514, Poland
Organization Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de Recherche Clinique (CRC) (Clinical Research Center)
NOT_YET_RECRUITING

Créteil, 94010, France
Pineo Medical Ecosystem LtD
NOT_YET_RECRUITING

Tbilisi, 0114, Georgia
Policlinico Paolo Giaccone University Hospital
NOT_YET_RECRUITING

Palermo, 90127, Italy
Református Pulmonológiai Intézet
NOT_YET_RECRUITING

Törökbálint, 2045, Hungary
Regina Elena Institute for Cancer Research
NOT_YET_RECRUITING

Roma, 00144, Italy
Semmelweis University Department of Pulmonology
NOT_YET_RECRUITING

Budapest, 1083, Hungary
St Luke's Hospital
NOT_YET_RECRUITING

Thessaloniki, 55236, Greece
Szpital Specjalistyczny w Prabutach Spolka z ograniczona odpowiedzialnoscia, Oddzial pulmonologii
NOT_YET_RECRUITING

Prabuty, 82-550, Poland
Szpitale Pomorskie Spolka z ograniczona odpowiedzialnoscia, Oddzial Onkologii i Radioterapii - Dzial Onkologii Klinicznej
NOT_YET_RECRUITING

Gdynia, 81-519, Poland
Tasman Oncology
NOT_YET_RECRUITING

Southport, Queensland, 4215, Australia
The First Medical Clinic LLC
NOT_YET_RECRUITING

Tbilisi, 0180, Georgia
Theageneio Anticancer Hospital
NOT_YET_RECRUITING

Thessaloniki, 54639, Greece
Total Health and Research Center
NOT_YET_RECRUITING

Miami, Florida, 33176, United States
UMHAT Sveti Ivan Rilski
NOT_YET_RECRUITING

Sofia, 1431, Bulgaria
Universite Pierre et Marie Curie (UPMC) - Center de Recherche des Cordeliers (CRC)
NOT_YET_RECRUITING

Paris, 75005, France
University Clinical Center Kragujevac
NOT_YET_RECRUITING

Kragujevac, 34000, Serbia
University Clinical Centre of Serbia, Clinic for pulmonology
NOT_YET_RECRUITING

Belgrade, 11000, Serbia
University Hospital Medical Center Bezanijska Kosa
NOT_YET_RECRUITING

Belgrade, 11000, Serbia
University of Sherbrooke
NOT_YET_RECRUITING

Greenfield Park, Quebec, J4V 2H1, Canada
Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, Raka Pluca i Chorob Wewnetrznych
NOT_YET_RECRUITING

Bialystok, 15-540, Poland
Valkyrie Clinical Trials
RECRUITING

Los Angeles, California, 90067, United States
Virginia Cancer Specialists
RECRUITING

Fairfax, Virginia, 22031, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.