NCT05922345 Evaluation of the Efficacy and Safety of AL2846 Capsule Combined With TQB2450 Injection Compared to Docetaxel Injection in Advanced Non-small Cell Lung Cancer Patients Who Have Failed With Immunotherapy.
| NCT ID | NCT05922345 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 518 participants |
| Start Date | 2023-06-08 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 518 participants in total. It began in 2023-06-08 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To investigate the efficacy of AL2846 capsules in combination with TQB2450 injection or Docetaxel injection in patients with advanced NSCLC who have previously failed immune checkpoint inhibitors (anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody), regardless of new anti-tumor treatment and early termination of treatment.
Eligibility Criteria
Inclusion Criteria: * The subjects voluntarily joined the study, signed an informed consent form, and had good compliance * Age: 18-75 years; Eastern Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; BMI ≥ 17 at baseline; * Patients with histologically or cytologically confirmed inoperable and inoperable locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) nonsmall-cell lung cancer (NSCLC) who cannot receive radical concurrent chemoradiotherapy; * Failure of platinum-based chemotherapy and immune checkpoint inhibitors for incurable locally advanced or metastatic or recurrent NSCLC; * Number of lines of prior systemic therapy received for locally advanced or metastatic/recurrent disease that is unresectable/not amenable to radical chemoradiation; * Confirmed to have at least one measurable lesion according to Response Evaluation Criteria In Solid Tumours（ RECIST 1.1） standard; * Adequate major organ function; Exclusion Criteria: * Patients who Have been diagnosed or currently had other malignant tumors; * Presence of epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, c-ros oncogene 1 (ROS1) fusion and other significant driver gene mutations; * Factors affecting oral drugs; * Major surgical treatment, incisional biopsy or obvious traumatic injury and long-term uncured wound or fracture within 28 days before the start of study treatment; * Hyperactive/venous thrombotic events within 6 months; * Subjects with any severe and/or uncontrolled disease; * Previously received other immunotherapy and Research Advance of Small Molecular Targeted Anti-Tumor Agents Tyrosine kinase inhibitors (TKIs); * According to the investigator's judgment, there are concomitant diseases that seriously endanger the subject's safety or affect the completion of the study, or there are other reasons that are not suitable for the subject;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05922345 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05922345 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 518 participants.
Is NCT05922345 currently recruiting?
Yes, NCT05922345 is actively recruiting participants. Contact the research team at dingzhi72@163.com for enrollment information.
Where is the NCT05922345 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT05922345 clinical trial?
NCT05922345 is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. The trial plans to enroll 518 participants.
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