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Advanced Lung CancerPhase 2NCT05815862

Clinical Study of AL2846 Capsules in the Treatment of Advanced Lung Tumor and Advanced Ovarian Cancer

A Phase 2 study testing AL2846 capsule in people with Advanced Lung Cancer and Ovarian Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-cohort, randomized, open, multicenter Phase II study to evaluate the efficacy and safety of AL2846 capsules in patients with advanced lung cancer and ovarian cancer. Objective response rate (ORR) and progression-free survival (PFS) are the primary endpoints. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Lung Cancer, Ovarian Cancer
What is being tested?
AL2846 capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
4 sitesChina
Study dates
15 Feb 2023to 20 Aug 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with advanced lung cancer or ovarian cancer confirmed by histopathology or cytology;
  • Age: 18~75 years old (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) score: 0-1;
  • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1;
  • Normal function of main organs
  • The serum Human Chorionic Gonadotropin (HCG) test of female patients of childbearing age must be negative within 7 days before study enrollment and must be non-lactating; The patient should agree to use contraception during the study period and within 6 months after the end of the study period;Male subjects should agree to use contraception during the study period and for 6 months after the study period ends;
  • The patient voluntarily joined the study and signed the informed consent form, with good compliance.

Who cannot join

  • Combined with the following diseases or medical history:
  • Other malignant tumors have occurred or are present at the same time within<3 years before the first administration.
  • Inability to tolerate multiple factors affecting oral medication due to any reason;
  • Common Terminology Criteria for Adverse Events (CTCAE) 5.0 > grade 1 therapeutic toxicity caused by any previous treatment that has not been completely relieved, excluding hair loss;
  • Major surgical treatment or obvious traumatic injury was received within 4 weeks before the first administration;
  • The presence of unhealed wounds, fractures, gastric and duodenal active ulcers, persistent positive fecal occult-blood, ulcerative colitis, or other conditions determined by investigators that may cause gastrointestinal bleeding or perforation;
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  • Arteriovenous thrombosis, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc., occurred within 6 months before the first medication;
  • Those who have a history of psychotropic drug abuse and cannot abstain or have mental disorders;
  • Subjects with any severe and/or uncontrollable disease；
  • Tumor related symptoms and treatment:
  • Had received chemotherapy, radiation, or other anticancer therapy within 4 weeks prior to first dose;
  • Within 2 weeks before the first dose, received Chinese Traditional drugs with anti-tumor indications specified in theNational Medical Products Administration (NMPA) approved drug instructions
  • Previously treated with anti-angiogenic drugs such as Cabozantinib, Anlotinib, Endostar and Bevacizumab;
  • Imaging Computed Tomography (CT)or Magnetic Resonance Imaging (MRI) shows that the tumor has invaded important blood vessels or the investigator determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study;
  • There is a history of interstitial lung disease, severe impairment of lung function, severe pulmonary fibrosis, severe radiation pneumonia, drug-induced lung disease, and evidence of severe active lung inflammation indicated by chest CT examination during screening;
  • There are uncontrolled pleural effusion, ascites and moderate or above pericardial effusion requiring repeated drainage;
  • Patients with brain metastases accompanied by symptoms or symptoms controlled for less than 2 weeks;
  • Patients who have participated in and used other antitumor investigational drugs within 4 weeks before the first dose;
  • Central squamous cell carcinoma (lung cancer subjects) with great risk of hemoptysis;
  • Patients with concomitant diseases that, in the opinion of the investigators, seriously endanger the safety of the patients or affect the completion of the study, or who are not suitable for inclusion for other reasons.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225009

Other trials in China

About this study

Official title: A Multi-cohort, Randomized, Open, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AL2846 Capsules in Treated Subjects With Advanced Solid Tumors

This is a multi-cohort, randomized, open, multicenter Phase II study to evaluate the efficacy and safety of AL2846 capsules in patients with advanced lung cancer and ovarian cancer. Objective response rate (ORR) and progression-free survival (PFS) are the primary endpoints.

Being tested
AL2846 capsule
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AL2846 capsuleDrug

    AL2846 is a multi-target tyrosine kinase inhibitor.

Study groups in NCT05815862
Study groupRoleWhat they receive
AL2846 capsuleExperimentalorally administer AL2846 capsules monotherapy, 28 days as a treatment cycle.
Receives: Drug: AL2846 capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective remission rate (ORR)

    ORR is defined as the percentage of subjects in complete remission (CR), partial remission (PR), and disease stability (SD).

    Measured: From baseline up to 12 months.

  2. Progression free survival (PFS)

    PFS is defined as the time from randomization to the first recorded progressive disease (PD) or death from any cause.

    Measured: From baseline up to 12 months.

Secondary outcomes (8)

  1. Disease control rate (DCR)

    Percentage of subjects achieving complete response (CR) and partial response (PR).

    Measured: From baseline up to 12 months.

  2. Duration of remission (DOR)

    The time from the first evaluation as CR or PR to the first evaluation as PD or death from any cause.

    Measured: From baseline up to 12 months.

  3. Overall survival (OS)

    Time from the first administration to death from any cause.

    Measured: From baseline to the death events, assessed up to 3 years.

  4. Adverse events (AEs) rate

    Occurrence of all adverse events, regardless of whether there was a causal relation with the studied drug.

    Measured: From baseline to 28 days after the last dose or initiation of a new antineoplastic therapy (whichever comes first).

  5. Peak concentration (Cmax)

    Maximum plasma drug concentration

    Measured: Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days.

  6. Time to peak concentration (Tmax)

    Time to reach peak plasma drug concentration after dose.

    Measured: Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days.

  7. Clearance half life (t1/2)

    The time it takes for the drug concentration in the body to drop by half

    Measured: Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days.

  8. Area under blood concentration-time curve (AUC)

    After administration, the area under the curve is obtained using the blood drug concentration as the ordinate and time as the abscissa.

    Measured: Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start15 Feb 2023
  3. Primary completion20 Aug 2025
  4. Study completion20 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05815862
Sponsor's protocol ID
AL2846-II-03
Status last verified
Aug 2025
First submitted
4 Apr 2023
Last updated
29 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AL2846 capsule in people with Advanced Lung Cancer and Ovarian Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective remission rate (ORR) (time frame: From baseline up to 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05815862.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.

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