New drug cocktail aims to fight advanced lung cancer
NCT ID NCT05014815
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested whether adding an experimental immunotherapy drug (ociperlimab) to a standard immunotherapy (tislelizumab) plus chemotherapy could help people with advanced non-small cell lung cancer. The trial involved 272 patients whose cancer had spread or could not be removed by surgery. Researchers measured how long patients lived without their cancer getting worse and how many saw their tumors shrink.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ociperlimab and tislelizumab (immunotherapy drugs) plus chemotherapy
- What this could lead to
- If successful, this combination could offer a new first-line treatment option for advanced lung cancer, potentially improving how long patients live without their cancer growing.
- What could go wrong
- This is a Phase 2 trial, so results are still early. The added drug may not improve outcomes over standard chemo-immunotherapy, and combination treatments often have more side effects.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
272 people
The number who actually took part.
- Started
-
Nov 2021
- Finished
-
Sep 2024
- 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 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.
Key Inclusion Criteria: 1. Participants had histologically or cytologically confirmed locally advanced or recurrent non-small cell lung cancer (NSCLC) that was not eligible for curative surgical resection and/or definitive radiotherapy, with or without chemotherapy. Alternatively, participants had metastatic non-squamous or squamous NSCLC. 2. Participants had not received any prior systemic therapy for locally advanced or metastatic squamous or non-squamous NSCLC, including but not limited to chemotherapy or targeted therapies. Those who had previously received neoadjuvant or adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease, were required to have experienced a disease-free interval of at least 6 months from the last dose of chemotherapy and/or concurrent radiotherapy prior to randomization. 3. Archival tumor tissue or a fresh biopsy (if archival tissue was unavailable) was required for programmed death-ligand 1 (PD-L1) level assessment and retrospective biomarker analyses. Only participants with evaluable PD-L1 results were considered eligible. 4. Participants were required to have had at least one measurable lesion as assessed by the investigator in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 5. Participants had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. Key Exclusion Criteria: 1. Participants were excluded if they had known mutations in any of the following genes: * Epidermal Growth Factor Receptor (EGFR): For participants with non-squamous NSCLC and unknown EGFR mutation status, tissue-based EGFR testing (performed either locally or at a central laboratory) or an endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)-based EGFR test was required prior to enrollment. Those found to harbor EGFR-sensitizing mutations were excluded. * Anaplastic Lymphoma Kinase (ALK) fusion oncogene. * B-Raf Proto-Oncogene (BRAF) V600E mutation. * ROS Proto-Oncogene 1 (ROS1) rearrangement. 2. Participants who had received prior treatment with EGFR inhibitors, ALK inhibitors, or other targeted therapies for known driver mutations. 3. Participants who had received any prior therapies targeting T-cell costimulatory or checkpoint pathways (e.g., programmed cell death protein 1 \[PD-1\], programmed death-ligand 1 \[PD-L1\], or cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\]) for metastatic NSCLC were excluded. 4. Participants who had any condition requiring systemic treatment with corticosteroids at a dose greater than 10 mg of prednisone (or equivalent) daily, or other immunosuppressive medications within 14 days prior to randomization. 5. Participants who had an active infection, including but not limited to tuberculosis, requiring systemic antibacterial, antifungal, or antiviral treatment within 14 days prior to randomization were excluded. Note: Additional protocol-defined inclusion and exclusion criteria may have applied.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Locally advanced, unresectable, or metastatic nonsmall cell lung cancer (NSCLC) are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Ajou University Hospital
Suwon, 16499, South Korea
-
Ansteel Group General Hospital
Anshan, Liaoning, 114000, China
-
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
-
Border Medical Oncology
East Albury, New South Wales, 2640, Australia
-
Cancer Care Northwest
Spokane Valley, Washington, 99216-1020, United States
-
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, 510030, China
-
Centre Hospitalier Regional Universitaire de Caen
Caen, 14000, France
-
Centro Oncologico de Galicia
A Coruña, 15009, Spain
-
Ch Provincial de Castellon
Castellon, 50009, Spain
-
Cha Bundang Medical Center, Cha University
BundangGu SeongnamSi, Gyeonggi-do, 13496, South Korea
-
Changzhou Cancer Hospital
Changzhou, Jiangsu, 213001, China
-
Complejo Asistencial Universitario de Leon
León, 24071, Spain
-
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, 89169-3321, United States
-
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042, China
-
Dong A University Hospital
Seogu, Busan Gwang'yeogsi, 49201, South Korea
-
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
-
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
-
Fundacion Instituto Valenciano de Oncologia Ivo
Valencia, 46009, Spain
-
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 06273, South Korea
-
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
-
Hopital Charles Nicolle Clinique Pneumologique
Rouen, 76000, France
-
Hopital Europeen Georges Pompidou
Paris, 75015, France
-
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
-
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040, China
-
Huzhou Central Hospital
Huzhou, Zhejiang, 313003, China
-
Institut Curie
Paris, 75005, France
-
Jingzhou Central Hospital
Jingzhou, Hubei, 434020, China
-
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 321000, China
-
Kangbuk Samsung Hospital
JongnoGu, Seoul Teugbyeolsi, 03181, South Korea
-
Klinik Penzing Wien, Abteilung Fur Atemwegs
Vienna, 1140, Austria
-
Korea University Guro Hospital
GuroGu, Seoul Teugbyeolsi, 08308, South Korea
-
Launceston General Hospital
Launceston, Tasmania, 7250, Australia
-
Liaocheng Peoples Hospital
Liaocheng, Shandong, 252000, China
-
North Shore Hematology Oncology Associates Dba New York Cancer and Blood Specialists
Port Jefferson Station, New York, 11776-8066, United States
-
North Shore Hematology Oncology Associates Dba New York Cancer and Blood Specialists (New York)
New York, New York, 10028-0517, United States
-
Northern Beaches Hospital
Frenchs Forest, New South Wales, 2086, Australia
-
Ny Cancer and Blood Specialists
The Bronx, New York, 10469-5930, United States
-
Olivia Newton John Cancer Wellness and Research Centre
Heidelberg, Victoria, 3084, Australia
-
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199, Australia
-
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444, Australia
-
Rj Zuckerberg Cancer Center
New Hyde Park, New York, 11042-1118, United States
-
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351, South Korea
-
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080, South Korea
-
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea
-
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
-
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
-
St Lukes Hospital
Thessaloniki, 55236, Greece
-
Tennessee Cancer Specialist
Knoxville, Tennessee, 37909-1327, United States
-
Texas Oncology Tyler Longview
Austin, Texas, 78705-1163, United States
-
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
-
The First Hospital of Jiaxing
Jiaxing, Zhejiang, 314001, China
-
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
-
The First Peoples Hospital of Chenzhou
Chenzhou, Hunan, 423000, China
-
The First Peoples Hospital of Kashgar
Kashgar, Xinjiang, 844099, China
-
Toowoomba Hospital
Toowoomba, Queensland, 4350, Australia
-
Townsville University Hospital
Douglas, Queensland, 4814, Australia
-
Ulsan University Hospital
Donggu, Ulsan Gwang'yeogsi, 44033, South Korea
-
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1009, United States
-
Valkyrie Clinical Trials
Los Angeles, California, 90067-2011, United States
-
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
-
Xcancerdayton Physician Network
Dayton, Ohio, 45409-1328, United States
-
Xinqiao Hospital Affiliated to the Army Medical University
Chongqing, Chongqing Municipality, 400037, China
-
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
-
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, 310014, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.