New drug cocktail shows promise for tough lung cancer
NCT ID NCT05351788
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new combination of drugs (SKB264 plus KL-A167, with or without chemotherapy) in about 110 adults with advanced or metastatic non-small cell lung cancer. The goal is to see if the treatment is safe and can shrink tumors or slow cancer growth. Participants must have a specific type of lung cancer that has not been treated much before.
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
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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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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- 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 to 75 years
- 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: 1. Males or females ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form; 2. Histologically and cytologically confirmed NSCLC; 3. Cohort 1: Patients with locally advanced/metastatic NSCLC with wild-type EGFR and negative ALK fusion gene, no or at most one prior line of systemic chemotherapy regimen for advanced or metastatic NSCLC. Cohort 2: Patients with locally advanced/metastatic NSCLC with wild-type EGFR and negative ALK fusion gene, no prior systemic therapy. Cohort 3: Patients with locally advanced/metastatic NSCLC with EGFR activating mutation and negative ALK fusion gene, who have failed previous treatment with EGFR-TKIs. 4. Provide fresh or archival tumor tissue for biomarker testing and analysis; 5. Patients with at least one measurable lesion per RECIST v1.1 criteria, and patients with only skin or bone lesions cannot be enrolled; 6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with an expected survival of ≥ 12 weeks; 7. Adequate organ and bone marrow function 8. For female patients of childbearing age and male patients with partners of childbearing age, they must use effective medical contraception during the study treatment period and for 6 months after the last dose of study medication (see Annex for specific contraceptive measures); 9. Each patient must voluntarily agree to participate in the study, sign the informed consent form, and comply with the protocol-specified visits and relevant procedures. Exclusion Criteria: 1. Presence of small cell lung carcinoma (SCLC) components in histological pathology; 2. History of other malignancies; 3. Presence of metastases to brainstem, meninges and spinal cord, or spinal cord compression; 4. Presence of active central nervous system (CNS) metastases; 5. Imaging (CT or MRI) shows that the tumor surrounds important blood vessels, or the investigator determines that the tumor is most likely to invade important blood vessels during the subsequent study to cause fatal major hemorrhage; 6. Serious or uncontrolled cardiac disease or clinical symptoms requiring treatment, including any of the following: 7. Patients with (noninfectious) interstitial lung disease (ILD) or history of pneumonia requiring steroid therapy; patients with serious pulmonary function impairment due to lung disease; 8. Uncontrolled systemic disease as judged by the investigator, included uncontrolled hypertension, uncontrolled diabetes, pesence of pleural effusion, pericardial effusion, or ascites that is clinically symptomatic or requires repeated drainage; 9. Certain viral infections including active hepatitis B or hepatitis C; known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); or positive syphilis antibody test; 10. Known active tuberculosis; 11. Known hypersensitivity to the study drug or any of its components, or severe allergic reactions to other monoclonal antibodies; 12. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 13. Pregnant or lactating women; 14. Any patient whose condition deteriorates rapidly during the screening process prior to the first dose, such as severe changes in performance status, unstable pain requiring adjustment of analgesic therapy, etc 15. 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Sun Yat-sen University Cancer Center
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510060, China
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, China
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- Two-Drug combo takes aim at Hard-to-Treat lung cancer