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New drug combo shows promise for tough lung cancers

NCT ID NCT05816252

Disease control Sponsor: Klus Pharma Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called SKB264, given alone or with other treatments, for people with advanced or spreading non-small cell lung cancer. About 356 adults with certain genetic types of lung cancer will take part. The goal is to see if the drug is safe and shrinks tumors.

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

356 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Dec 2026

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 1. Subjects must be at least 18 years of age on day of signing informed consent, regardless of gender; 2. Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC ; 3. Subjects for NSCLC should be confirmed to be EGFR (Epidermal growth factor receptor) wild-type and ALK (Anaplastic lymphoma kinase) fusion gene negative; or confirmed to harbor EGFR mutation; 4. Locally advanced or metastatic NSCLC subjects without actionable EGFR mutations and ALK fusion genes, no prior systemic treatment; subjects with EGFR mutation, no prior systemic treatment or failed prior EGFR-TKI (Tyrosine kinase inhibitor) treatment; 5. Subjects are able to provide tumor blocks or slides before the first dose of study intervention; 6. Subject must have at least one radiographically measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; 7. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1; 8. Life expectancy at least 3 months for the subject; 9. Adequate organ function; 10. Subjects must have recovered from all toxicities led by prior treatment; 11. Contraceptive methods used by male and female subjects must comply with contraceptive methods of local regulations for clinical study subjects; 12. Subjects should voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures. Exclusion Criteria 1. Subjects with mixed SCLC histopathological features; 2. Subjects with a known history of prior malignancy; 3. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active central nervous system (CNS) metastases; 4. Subjects with ≥ Grade 2 peripheral neuropathy; 5. Subjects who had arteriovenous thromboembolic events, tumor invasion/encasement of vital organs/vessels, risk of esophageal-tracheal/pleural fistula, or current superior vena cava syndrome; 6. Subjects with active inflammatory bowel disease or previous clear history of inflammatory bowel disease; 7. Subjects who suffer from cardiovascular diseases of clinical significance; 8. Subjects with a history of interstitial lung disease (ILD)/non-infectious pneumonitis that required steroids; 9. Subjects with uncontrolled systemic disease as judged by the Investigator; 10. Subjects with active autoimmune disease that required systemic treatment in the past 2 years; 11. Subjects with active hepatitis B or hepatitis C; 12. Subjects with known history of Human Immunodeficiency Virus (HIV) 13. Subjects with known active tuberculosis; 14. Subjects with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 15. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study; 16. Subjects whose condition deteriorated rapidly, such as severe changes in performance status, during the screening process prior to the first dose of study intervention; 17. Subjects with other circumstances that, in the opinion of the Investigator, are not appropriate for participation in this study.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

Non-small cell lung cancer

Contacts and locations

Locations

  • Adana City Training and Research Hospital

    Adana, 01370, Turkey (Türkiye)

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Centrul de Oncologie Sf. Nectarie

    Craiova, Dolj, 200542, Romania

  • Chengdu Fifth People's Hospital

    Chengdu, Sichuan, 611130, China

  • Chongqing University Cancer Hospital (Chongqing Cancer Hospital)

    Chongqing, Chongqing Municipality, 400000, China

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Gazi University Medical Faculty

    Ankara, 06500, Turkey (Türkiye)

  • Guangxi Cancer Hospital/ Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530021, China

  • Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi

    Ankara, 06010, Turkey (Türkiye)

  • Hacettepe University Medical Faculty

    Ankara, 06230, Turkey (Türkiye)

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou University

    Zhengzhou, Henan, 45008, China

  • Hospital Clinico Universitario De Valencia

    Valencia, 46010, Spain

  • Hospital Quironsalud Malaga

    Málaga, 29004, Spain

  • Hospital Universitari Dexeus Grupo Quironsalud

    Barcelona, 08028, Spain

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Puerta De Hierro De Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario QuirónSalud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario Virgen de Valme

    Seville, 41014, Spain

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • ISR-GEO Med Res Clin Healthycore

    Tbilisi, 0112, Georgia

  • Inje University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

    Cluj-Napoca, Cluj, 400015, Romania

  • Jilin Cancer Hospital

    Changchun, Jilin, 130021, China

  • LLC "Todua Clinic"

    Tbilisi, 0112, Georgia

  • Ltd New Hospitals

    Tbilisi, 0114, Georgia

  • Medical Park Seyhan Hospital

    Adana, 01140, Turkey (Türkiye)

  • Micancer Center S.L.P.

    Barcelona, 08017, Spain

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi, 6351, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong, 250117, China

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 30009, China

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041, China

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • Sun Yatsen University Cancer Center Huangpu Hos

    Guangzhou, Guangdong, 510700, China

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggido, 16247, South Korea

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital of Zhengzhou University(Heyi Compus)

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Chinese Medical University(Heping Compus)

    Shenyang, Liaoning, 110002, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071, China

More trials for these conditions

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