New combo therapy shows promise for aggressive lung cancer
NCT ID NCT04702880
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding an experimental drug (BMS-986012) to standard chemotherapy and immunotherapy could help people with advanced small cell lung cancer live longer without their cancer growing. The trial involved 135 newly diagnosed patients. Researchers measured safety and how well the treatment worked compared to standard care alone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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135 people
The number who actually took part.
- Started
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Mar 2021
- Finished
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Nov 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 documented extensive-stage small cell lung cancer (ES-SCLC) and extensive-stage disease (American Joint Committee on Cancer, 8th edition, Stage IV \[T any, N any, M1a, M1b, or M1c\], or T3-4 due to multiple lung nodules that are too extensive or tumor or nodal volume that is too large to be encompassed in a tolerable radiation plan) * Participants taking part in the separate PET tracer sub-study must provide a fresh tumor biopsy from any disease site (primary or metastatic) * Archived tumor specimens, in the form of blocks or sectioned slides, are mandatory for all participants except those participating in the separate PET tracer sub-study for whom the archived tumor specimen is optional * Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 * At least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria * Adequate hematologic and end organ function * Must agree to follow specific methods of contraception, if applicable Exclusion Criteria: * Women who are pregnant or breastfeeding. Japan only: participation in the study is not allowed even if breastfeeding is suspended * Prior chemotherapy, radiation therapy, or biologic therapy for SCLC. Previously treated limited stage SCLC (LS-SCLC) participants are also excluded * Symptomatic brain or other central nervous system (CNS) metastases * Paraneoplastic autoimmune syndrome requiring systemic treatment * History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan * Grade ≥ 2 peripheral sensory neuropathy at study entry * Significant uncontrolled cardiovascular disease * Active, known or suspected autoimmune disease or inflammatory disorder Other protocol-defined inclusion/exclusion criteria apply
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Local Institution
Cincinnati, Ohio, 45267, United States
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Local Institution
Dallas, Texas, 75390, United States
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Local Institution - 0001
Malvern, Victoria, 3144, Australia
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Local Institution - 0002
Durham, North Carolina, 27710, United States
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Local Institution - 0003
Westmead, New South Wales, 2145, Australia
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Local Institution - 0004
Murdoch, Western Australia, 6150, Australia
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Local Institution - 0005
Majadahonda, 28222, Spain
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Local Institution - 0006
Málaga, 29010, Spain
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Local Institution - 0007
Barcelona, Barcelona [Barcelona], 08035, Spain
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Local Institution - 0012
Edmonton, Alberta, T6G 1Z2, Canada
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Local Institution - 0021
Madrid, 28041, Spain
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Local Institution - 0022
Hackensack, New Jersey, 07601, United States
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Local Institution - 0023
Greenslopes, Queensland, 4120, Australia
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Local Institution - 0029
Rozzano, 20089, Italy
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Local Institution - 0030
Peschiera del Garda, 37019, Italy
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Local Institution - 0031
Pisa, 56124, Italy
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Local Institution - 0034
Ghent, 9000, Belgium
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Local Institution - 0036
Athens, 11527, Greece
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Local Institution - 0038
Athens, 185 47, Greece
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Local Institution - 0039
Amsterdam, North Holland, 1081 HV, Netherlands
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Local Institution - 0040
Groningen, 9700RB, Netherlands
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Local Institution - 0041
Craiova, 200542, Romania
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Local Institution - 0042
Cluj-Napoca, 400015, Romania
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Local Institution - 0043
Bucharest, 022328, Romania
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Local Institution - 0045
Heraklion, Irakleío, 715 00, Greece
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Local Institution - 0048
Lodz, 93-338, Poland
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Local Institution - 0049
Gdansk, 80-214, Poland
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Local Institution - 0050
Liège, 4000, Belgium
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Local Institution - 0051
Charleroi, Hainaut, 6060, Belgium
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Local Institution - 0060
Cincinnati, Ohio, 45267, United States
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Local Institution - 0064
Brampton, Ontario, L6R 3J7, Canada
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Local Institution - 0066
Arnhem, 6815 AD, Netherlands
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Local Institution - 0067
Cleveland, Ohio, 44106-1716, United States
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Local Institution - 0069
Takatsuki, Osaka, 5698686, Japan
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Local Institution - 0070
Ōsaka-sayama, Osaka, 589-8511, Japan
-
Local Institution - 0073
Sendai, Miyagi, 980-0873, Japan
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Local Institution - 0075
Birmingham, Alabama, 35249, United States
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Local Institution - 0077
Ina-machi, Saitama, 362-0806, Japan
-
Local Institution - 0081
Nashville, Tennessee, 37203, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Two-Drug combo outperform standard care in aggressive lung cancer?
- Can a targeted drug combo outperform standard care for aggressive lung cancer?
- Can a Two-Drug attack shrink tough lung cancers?
- Can a smartphone app ease the burden of advanced lung cancer?
- Cholesterol-Lowering drug may boost lung cancer immunotherapy
- Lung cancer drug tislelizumab under Real-World scrutiny in 440-Patient european study