> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/evaluation-of-jskn016-combination-therapy-in-subjects-with-2699a368-5716-48ec-b228-8a16fdd61b0b > Record changed: 2026-10-13 # Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC NCT06868732 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) Participants 288 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) Lead sponsor Jiangsu Alphamab Biopharmaceuticals Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) Start date 2025-04-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) ## Title and summary **Summary** This is a Phase Ib clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016 in combination therapy. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Short title** Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Official title** Evaluation of JSKN016 Combination Therapy in Subjects With Advanced Non-Small Cell Lung Cancer: A Phase Ib Study Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) ## Dates **Completion date** 2028-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **First posted** 2025-03-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Registry last updated** 2026-03-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Primary completion date** 2028-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Start date** 2025-04-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) ## Size and sites **Participants** 288 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Planned participants** 288 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Lead sponsor** Jiangsu Alphamab Biopharmaceuticals Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) ## Identifiers **Registry ID** NCT06868732 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **ClinicalTrials.gov ID** NCT06868732 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) ## Outcomes ### Primary outcomes 1. ORR assessed by the investigator per RECIST v1.1 Timeframe: Up to 24months Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response \\\[CR\\\] or partial response \\\[PR\\\] per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) 2. Safety reflected by AE Timeframe: Up to 24months An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. ### Secondary outcomes 1. DOR assessed by the investigator per RECIST v1.1 Timeframe: Up to 24months Duration of response (DoR) assessed according to RECIST v1.1. 2. DCR assessed by the investigator per RECIST v1.1 Timeframe: Up to 24months Disease control rate (DCR) assessed according to RECIST v1.1. 3. TTR assessed by the investigator per RECIST v1.1 Timeframe: Up to 24months Time to response (TTR) is defined as the time to response base on RECIST v1.1. 4. PFS assessed by investigator per RECIST v1.1 Timeframe: Up to 24months Progression-free survival (PFS) is defined as the time from the date of initial administration till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first). 5. OS Timeframe: Up to 24months Overall Survival (OS) is defined as the time from the date of initial administration till death due to any cause. 6. Peak Plasma Concentration (Cmax) Timeframe: Up to 24months The Peak Plasma Concentration (Cmax) of the antibody-drug conjugate (ADC), total antibody and free payload. 7. Trough Plasma Concentration (Cmin) Timeframe: Up to 24 months The Trough Plasma Concentration (Cmin) of the antibody-drug conjugate (ADC), total antibody and free payload. 8. ADA Timeframe: Up to 24months Number of subjects with detectable anti-drug antibodies (ADA). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. Voluntarily participate and sign the informed consent form. 2. Age ≥ 18 years old, ≤ 75 years old, male or female. 3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1. 4. Expected survival ≥ 3 months. 5. Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not suitable for radical surgery and/or radical radiotherapy. 6. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria. 7. Recently archived or fresh tumor tissue samples are available. 8. Have good organ function. 9. Have no current birth plans and agree to contraception during the trial. ### Exclusion criteria 1. Presence of any small cell carcinoma component in histopathology. 2. Subjects with other malignant tumors within 5 years prior to enrollment, and other tumors have been cured through local therapy, such as cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-primary invasive bladder cancer, and prostate/cervical/breast cancer in situ. 3. Presence of brainstem, meningeal metastases, spinal cord metastases or compression, leptomeningeal metastases, or history of carcinomatous meningitis; Presence of active brain metastases. 4. During the screening period, imaging shows that the tumor invades, compresses, or occurs in the surrounding important organs (such as the heart and pericardium, trachea, esophagus, superior vena cava, etc.) or there is a risk of esophageal tracheal fistula or esophageal pleural fistula. 5. Adequate washout of previous therapy before the first dose. 6. Gastrointestinal abnormalities with obvious clinical manifestations. 7. Presence of clinically severe respiratory impairment caused by pulmonary disease complications. 8. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors. 9. Prior treatment with topoisomerase I inhibitors (e.g., irinotecan, topotecan), antibody-drug conjugates containing topoisomerase I inhibitors (e.g., DS-8201, HER3-DXd, DS-1062), or targeting TROP2 or HER3. 10. Previous treatment with docetaxel. 11. Have an uncontrolled infection, a history of immunodeficiency, a positive human immunodeficiency virus (HIV) test, or a history of AIDS. 12. Previous history of allogeneic bone marrow or organ transplantation. 13. Known allergy to any component of the study drug, and previous history of severe allergic reaction to other antibody drugs. 14. Pregnant and/or lactating females. 15. Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risk and/or uncertainty in survival evaluation, such as tumor leukemia response , cachexia manifestations, etc. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) ## Sites - Sun Yat-sen University Cancer CenterGuangzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868732) ## Related records ### Drugs (6) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Docetaxel](https://trialight.com/data/asset/docetaxel-3c835086-a86f-4a89-abb6-45847fbab5d6.md) - [Firmonertinib mesylate](https://trialight.com/data/asset/firmonertinib-mesylate-ebbdcb6b-1812-4e52-aac8-773369fa8282.md) - [Ivonescimab](https://trialight.com/data/asset/ivonescimab-abc25b61-44c5-4a6f-99eb-c59828f17211.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Tislelizumab](https://trialight.com/data/asset/tislelizumab-70601caf-7705-4f05-b211-e6a4d4556fe3.md) ### Lead sponsors (1) - [Jiangsu Alphamab Biopharmaceuticals Co., Ltd](https://trialight.com/data/company/jiangsu-alphamab-biopharmaceuticals-co-ltd-ce4da3fe-a3dc-44d9-b108-f125f3dffe3f.md) ### Conditions (1) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition ### Targets (16) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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