A Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy.
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT06421298
- Lead Sponsor
- Jinghui Wang
- Brief Summary
The second-line treatment for patients who have progressed after first-line immune checkpoint inhibitor therapy, is chemotherapy based on docetaxel and other drugs. The treatment effect is limited. The median survival time of them are 6 months. So there is a huge unmet medical need.
This study is a Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy. 30 patients will be enrolled.
The main endpoint is PFS，and the secondary endpoint are OS,DCR,DOR,ORR, and so on.
- Detailed Description
This is a Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy.
30 patients will be enrolled. These patients will be treated with chemotherapy combined with sintilimab and Tafolecimab.
The main endpoint is PFS，and the secondary endpoint are OS,DCR,DOR,ORR, and so on.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
- The pathology is small cell lung cancer (SCLC), including lung cancer that is a mixture of SCLC and NSCLC;
- Have received the following treatments:
- Received systemic anti-tumor treatment within 3 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal treatment with anti-tumor indications), etc.; 2) Have received any investigational drug treatment within 4 weeks before treatment; 3) Received large doses of immunosuppressive drugs (systemic glucocorticoids exceeding 10 mg/day of prednisone or its equivalent) within 4 weeks before treatment; 4) Have received live attenuated vaccines within 4 weeks before treatment (or plan to receive live attenuated vaccines during the study); 5) Have undergone major surgery (such as open cavity, thoracotomy or Kaifu surgery) within 4 weeks before treatment, or have unhealed surgical wounds, ulcers or fractures.
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There is clinically uncontrollable pleural effusion/abdominal effusion (subjects who do not need to drain the effusion or who stop drainage for 3 days without significant increase in effusion can be enrolled);
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Subjects who have received chest radiation therapy greater than 30Gy within 6 months before treatment or palliative radiation therapy with a dose of 30Gy or less within 7 days before treatment (palliative treatment for bone lesions or intracranial lesions is allowed) Radiation Therapy);
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Active autoimmune disease that requires systemic treatment (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;
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Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
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Those who are known to be allergic to the active ingredients or excipients of tolesimab, the study drug;
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Have not fully recovered from toxicity and/or complications caused by any intervention before initiating treatment (i.e., ≤Grade 1 or reaching baseline, excluding fatigue or alopecia);
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Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
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Untreated active hepatitis B (defined as HBsAg positivity and a detected HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the research center);
Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
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If the HBV viral load is <1000 copies/ml (200 IU/ml) before the first dose, the subject should receive anti-HBV treatment during the entire study chemotherapy drug treatment period to avoid viral reactivation.
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Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV treatment, but need to be closely monitored for viral reactivation
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Subjects with active HCV infection (HCV antibody positive and HCV-RNA level higher than the lower limit of detection);
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Get live vaccine within 30 days before the first dose (cycle 1, day 1); Note: Injectable inactivated virus vaccine against seasonal influenza is allowed within 30 days before the first dose; however, intranasal live attenuated influenza vaccine is not allowed.
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Pregnant or lactating women;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tafolecimab and Sintilimab Combined With Chemotherapy Nab paclitaxel tafolecimab sintilimab nab-paclitaxel docetaxel gemcitabine Tafolecimab and Sintilimab Combined With Chemotherapy Sintilimab tafolecimab sintilimab nab-paclitaxel docetaxel gemcitabine Tafolecimab and Sintilimab Combined With Chemotherapy Tafolecimab tafolecimab sintilimab nab-paclitaxel docetaxel gemcitabine Tafolecimab and Sintilimab Combined With Chemotherapy Docetaxel tafolecimab sintilimab nab-paclitaxel docetaxel gemcitabine Tafolecimab and Sintilimab Combined With Chemotherapy Gemcitabine tafolecimab sintilimab nab-paclitaxel docetaxel gemcitabine
- Primary Outcome Measures
Name Time Method PFS up to 24 months PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
- Secondary Outcome Measures
Name Time Method OS up to 24 months OS is defined as the time until death due to any cause. OS is defined as the time until death due to any cause.
OS is defined as the time until death due to any cause.DCR up to 24 months Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
DOR up to 24 months defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier Defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier
ORR up to 24 months ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
AE up to 24 months Evaluation of adverse event rate according to CTCAE(Common terminology criteria for adverse events) v5.0
Trial Locations
- Locations (1)
Beijing Chest Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China