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Combining AL2846 capsules with TQB2450 injection for advanced lung cancer treatment

A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of AL2846 Capsules Combined With TQB2450 Injection Compared With Docetaxel Injection in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed With Immunotherapy.

PHASE3 · Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · NCT05922345

This study is testing if a new combination of AL2846 capsules and TQB2450 injection can help people with advanced lung cancer who haven't responded to other treatments feel better compared to a standard treatment.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment518 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd. (industry)
Drugs / interventionschemotherapy, immunotherapy
Locations71 sites (Hefei, Anhui and 70 other locations)
Trial IDNCT05922345 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of AL2846 capsules in combination with TQB2450 injection compared to docetaxel injection in patients with advanced non-small cell lung cancer (NSCLC) who have previously failed immunotherapy. It aims to determine if this combination can provide better outcomes for patients who have not responded to prior treatments. Participants must have measurable lesions and meet specific health criteria to be eligible for the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced NSCLC who have failed prior immunotherapy and have measurable disease.

Not a fit: Patients with early-stage lung cancer or those who have not received prior immunotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced NSCLC who have limited treatment choices.

How similar studies have performed: Other studies have explored similar combinations in lung cancer treatment, showing promising results, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion 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;

Where this trial is running

Hefei, Anhui and 70 other locations

+21 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-small Cell Lung Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.