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Taking people in ChinaPhase 2/3

Tests navlimetostat with pembrolizumab and chemotherapy in lung cancer with MTAP deletion

Tests navlimetostat plus pembrolizumab and chemotherapy in adults with advanced lung cancer.

Plain-language title generated from the registry record
Registry title: A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

Key facts

Where
Beijing, Changchun, Changsha, Chengdu, Chongqing, Fuzhou, Guangzhou, Guiyang, Hangzhou, Harbin, Hefei, Jinan, Linyi, Nanchang, Nanjing, Nanning, Qingdao, Shanghai, Shenyang, Shenzhen, Shijiazhuang, Taiyuan, Wuhan, Xi'an, Xiamen, and Zhengzhou, ChinaSee the 43 sites
Phase
Phase 2/3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with metastatic non-small cell lung cancer who have not had treatment for the spread of the disease and whose tumour has an MTAP deletion or MTAP loss.

Age
18 years or older
Sex
All sexes can join
Disease stage
Metastatic (Stage IV or recurrent) non-small cell lung cancer, confirmed under the microscope. At least 1 measurable tumour (RECIST v1.1). ECOG performance status 0-1.
Earlier treatment
No earlier systemic cancer treatment (chemotherapy, immunotherapy, targeted or biological therapy) for metastatic disease. One cycle of standard treatment before randomization is allowed if immediate treatment is needed.
Biomarker or test result
Homozygous MTAP deletion or MTAP loss.

Main reasons for not taking part

  • Nonsquamous cancer with a targetable gene change that has a standard first-line treatment
  • Symptomatic brain metastases or spinal cord compression
  • Any earlier systemic therapy for metastatic non-small cell lung cancer
  • Problems with the gut that stop swallowing or absorbing a pill without chewing or crushing it

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Which best describes your lung cancer?
  • Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
  • Can you look after yourself and are you up and about most of the day?
  • Has your cancer spread to the brain?

Source: NCT07063745, who can take part

Where in China

  • Beijing, Beijing MunicipalityHospital not named in the registryContact: Site 0621Not yet recruiting
  • Beijing, Beijing MunicipalityHospital not named in the registryContact: Site 0049Not yet recruiting
  • Beijing, Beijing MunicipalityHospital not named in the registryContact: Site 0286Not yet recruiting
  • Peking University People's HospitalBeijing, ChinaContact: Fan Yang, Site 0074Taking people
  • Changchun, JilinHospital not named in the registryContact: Site 0075Not yet recruiting
  • Changsha, HunanHospital not named in the registryContact: Site 0057Not yet recruiting
  • Changsha, HunanHospital not named in the registryContact: Site 0387Not yet recruiting
  • Hunan Cancer HospitalChangsha, ChinaContact: Lin Wu, Site 0050Taking people
  • Sichuan Cancer HospitalChengdu, ChinaContact: Wenxiu Yao, Site 0102Taking people
  • West China Hospital，Sichuan UniversityChengdu, ChinaContact: Yalun Li, Site 0109Taking people
  • Chongqing, Chongqing MunicipalityHospital not named in the registryContact: Site 0108Not yet recruiting
  • Fujian Cancer HospitalFuzhou, ChinaContact: Yunjian Huang, Site 0046Taking people
  • Guangzhou, GuangdongHospital not named in the registryContact: Site 0061Not yet recruiting
  • Guangdong Provincial People's HospitalGuangzhou, ChinaContact: Huibing Gao, Site 0443Taking people
  • The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaContact: Kejing Tang, Site 0099Taking people
  • Guiyang, GuizhouHospital not named in the registryContact: Site 0408Not yet recruiting
  • Hangzhou, ZhejiangHospital not named in the registryContact: Site 0069Not yet recruiting
  • The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaContact: Jianying Zhou, Site 0280Taking people
  • Zhejiang Cancer HospitalHangzhou, ChinaContact: Xinmin Yu, Site 0054Taking people
  • Harbin Medical University Cancer HospitalHarbin, ChinaContact: Yan Yu, Site 0106Taking people
  • Hefei, AnhuiHospital not named in the registryContact: Site 0072Not yet recruiting
  • Jinan, ShandongHospital not named in the registryContact: Site 0051Not yet recruiting
  • LinYi Cancer HospitalLinyi, ChinaContact: Jianhua Shi, Site 0066Taking people
  • The First affiliated hospital of Nanchang University (Xianghu campus)Nanchang, ChinaContact: Longhua Sun, Site 0110Taking people
  • Nanjing, JiangsuHospital not named in the registryContact: Site 0279Not yet recruiting
  • Nanjing, JiangsuHospital not named in the registryContact: Site 0352Not yet recruiting
  • Nanjing First HospitalNanjing, ChinaContact: Surong Fang, Site 0386Taking people
  • Guangxi Medical University Affiliated Cancer HospitalNanning, ChinaContact: Shaozhang Zhou, Site 0067Taking people
  • Qingdao, ShandongHospital not named in the registryContact: Site 0068Not yet recruiting
  • Shanghai Chest HospitalShanghai, ChinaContact: Hua Zhong, Site 0278Taking people
  • Zhongshan Hospital,Fudan UniversityShanghai, ChinaContact: Yong Zhang, Site 0343Taking people
  • Shenyang, LiaoningHospital not named in the registryContact: Site 0104Not yet recruiting
  • Shenyang, LiaoningHospital not named in the registryContact: Site 0284Not yet recruiting
  • Liaoning Cancer HospitalShenyang, ChinaContact: Hongxu Liu, Site 0103Taking people
  • Shenzhen, GuangdongHospital not named in the registryContact: Site 0281Not yet recruiting
  • Shijiazhuang, HebeiHospital not named in the registryContact: Site 0353Not yet recruiting
  • Taiyuan, ShanxiHospital not named in the registryContact: Site 0283Not yet recruiting
  • Hubei Cancer HospitalWuhan, ChinaContact: Bin Yang, Site 0059Taking people
  • Wuhan Union Hospital Cancer CenterWuhan, ChinaContact: Rui Meng, Site 0048Taking people
  • Xi'an, ShaanxiHospital not named in the registryNo longer taking part
  • The First Affiliated hospital of Xiamen UniversityXiamen, ChinaContact: Feng Ye, Site 0100Taking people
  • Zhengzhou, HenanHospital not named in the registryContact: Site 0047Not yet recruiting
  • Zhengzhou, HenanHospital not named in the registryContact: Site 0107Not yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Bristol-Myers Squibb
Trial code
NCT07063745EU 2025-521511-40-00
Record updated
23 October 2026
Original description
The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletionRead full original descriptionShow less

A Randomized Phase 2/3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion

Inclusion: Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease; Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss; Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Participants must have at least 1 measurable lesion as per RECIST v1.1.

Exclusion: Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy; Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC); Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated; Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing; Participants must not have symptomatic brain metastases or spinal cord compression; Other protocol-defined Inclusion/Exclusion criteria apply.

ClinicalTrials.gov NCT07063745 · EU CTIS 2025-521511-40-00