Non-small-cell Lung CancerPhase 2NCT06141226

Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Capsule and Chemotherapy in the Treatment of Immunoresistant Advanced Non-small Cell Lung Cancer

A Phase 2 study testing TQB2450 +Anlotinib+Docetaxel in people with Non-small-cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Objective to compare the efficacy and safety of TQB2450 injection combined with anlotinib and chemotherapy, and TQB2450 injection combined with chemotherapy in the treatment of advanced non-small cell lung cancer subjects who failed to receive first-line chemotherapy combined with immunization, and to explore and… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-small-cell Lung Cancer
What is being tested?: TQB2450 +Anlotinib+Docetaxel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 148 participants
Where: 5 sitesChina
Study dates: 12 Apr 2023to 30 Dec 2028
Phase: Phase 2
Are there results?: Not yet: the study is under way

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

According to the International Association for the Study of Lung Cancer and the Joint Committee on the American Classification of Cancer, 8th edition TNM staging of lung cancer, patients with locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) NSCLC who are histologically proven to be inoperable and unable to undergo radical synchronous radiotherapy and chemotherapy.
18 years old ≤ age ≤ 75 years old; No gender limit; ECOG score 0-1 points; The expected survival period is ≥ 3 months.
According to RECIST 1.1 standard, there should be at least one measurable lesion.
Tumor resistance has progressed after receiving first-line treatment with immune checkpoint inhibitors (including PD-1 or PD-L1 monoclonal or dual antibodies) combined with platinum based drugs in the past. For neoadjuvant/adjuvant chemotherapy or radiotherapy or concurrent radiotherapy and chemotherapy, if the disease progresses during treatment or within 6 months after discontinuation of treatment, it should be considered as a first-line treatment plan.
It is necessary to provide tumor tissue sections that have been diagnosed with advanced or metastatic NSCLC and have not undergone radiotherapy (at least 5 samples are required for PD-L1 testing of tumor tissue, but if testing has been conducted before the first line treatment, recognized test results from each participating center can be accepted.) Tumor tissue samples must be archived samples or freshly obtained samples within the first 12 months of randomization.
Except for patients with squamous NSCLC, enrolled patients need to demonstrate the absence of EGFR gene sensitive mutations, ALK fusion oncogenes, or ROS1 fusion oncogenes. If it is adenosquamous cell carcinoma, stratification needs to be determined based on the dominant tissue composition.

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Good function of main organs
Women of childbearing age should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study. Serum pregnancy or urine pregnancy tests should be negative within 7 days before enrollment in the study; Men should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study period.
The subjects voluntarily joined this study, signed an informed consent form, and had good compliance.

Who cannot join

Tumor diseases and medical history:
If there is a central nervous system metastasis before enrollment, enrollment can be made if all the following criteria are met: i. Previously received brain metastasis treatment and met all of the following criteria:
① Only supratentorial and cerebellar metastases are allowed (i.e. transfer to the midbrain, pons, medulla, or spinal cord is not allowed);
② No imaging evidence of new or enlarged brain metastases was found;
③ There are no symptoms of brain metastasis, and the subject must have stopped using corticosteroids/dehydrating agents for at least 2 weeks before starting to use the investigational drug.
Has not received brain metastasis treatment in the past and meets all of the following criteria:

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No more than 3 metastatic lesions; ② The total length and diameter of all lesions ≤ 1.5cm;
There are no neurological symptoms caused by brain tissue compression;
④ Before starting to use the investigational drug, the subject must have stopped using corticosteroids/dehydrating agents for at least 2 weeks.
There were no active malignant tumors for ≤ 2 years before randomization. c) Central type squamous cell carcinoma with a cavity (primary in the main bronchus and around the hilum of the lungs).
Imaging shows that the tumor invades large blood vessels, or the boundary between the tumor and the blood vessels is unclear, or the researcher determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies.
(1) Severe bone damage caused by tumor bone metastasis, including pathological fractures of load-bearing bones (such as spinal vertebrae, pelvis, femur, tibia, phalanges, calcaneus, etc.) and spinal cord compression that occur within 6 months; (2) Imaging examination suggests the presence of three or more multiple bone metastases in the load-bearing bone.
Patients with serous cavity (pleural, abdominal, or pericardial) effusion that requires repeated drainage to alleviate clinical symptoms (as determined by the researcher), or those who have received serous cavity effusion drainage for treatment purposes within 2 weeks prior to treatment.
Previous anti-tumor treatment:
Within 2 weeks before the start of the study treatment, he received traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the NMPA approved drug instructions.
I have previously used anti angiogenic drug systems such as arotinib, apatinib, lenvatinib, sorafenib, sunitinib, regofinib, and furoquitinib to treat locally advanced or metastatic NSCLC.
Previously received docetaxel for systematic treatment of locally advanced or metastatic NSCLC.
Unacceptable toxicity after previous anti PD - (L) 1 treatment.
Patients who have received medication with immunomodulatory effects within 30 days before starting treatment.
Before randomization, there are any symptoms that require systemic treatment with corticosteroids (prednisone or equivalent doses of similar drugs above 10 mg/d) or other immunosuppressive agents for ≤ 14 days.
Failure to recover from toxicity and/or complications of previous intervention measures to CTCAE ≤ 1 level, except for peripheral neuropathy with hair loss and ≤ 2 level.
Concomitant diseases and medical history:
Decompensated cirrhosis (Child Pugh liver function rating B or C), active hepatitis, and active COVID-19 infection.
Renal abnormalities: i. Renal failure requires hemodialysis or peritoneal dialysis; Ii. Previous or existing nephrotic syndrome (excluding cured), chronic nephritis.
Cardiovascular and cerebrovascular abnormalities: d) Gastrointestinal abnormalities: i. Inability to take medication orally; Ii. History of malabsorption syndrome or other diseases that can interfere with gastrointestinal absorption, including a history of partial surgical removal of the stomach or intestines (excluding appendectomy); Iii. Received treatment for active gastrointestinal ulcers within the past 6 months.
History of Immunodeficiency: i. Having a history of immunodeficiency, including HIV positive or suffering from other acquired or congenital immunodeficiency diseases; Ii. A history of active autoimmune diseases or autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, autoimmune hepatitis/enteritis/vasculitis/nephritis, etc; Iii. Prepare to undergo or have previously received organ transplantation; f) Bleeding risk: i. Suffering from bleeding, coagulation disorders, or using warfarin, aspirin, and other antiplatelet agglutination drugs within 28 days prior to the start of treatment (excluding preventive medication with aspirin ≤ 100 mg/d); Ii. Have a history of hemoptysis within 28 days before the start of treatment; Iii. Regardless of the severity, patients with congenital bleeding or coagulation disorders, or those who are currently using anticoagulants for treatment; Iv. Major surgical treatment or obvious traumatic injury received within 28 days prior to the start of the study treatment; v. Long term uncured wounds or fractures, excluding pathological fractures. g) Type I diabetes or II diabetes is poorly controlled. h) Having experienced severe infection of level 4 or higher within one year prior to the start of the study treatment; Subjects with 2-3 levels of active infection within 2 weeks prior to the start of study treatment; Treponema pallidum antibody (TP Ab) positive; Or those who experience unexplained fever of>38.0 ℃ during the screening period or before the first administration, or who require medical intervention.
Previous or existing pneumoconiosis, interstitial pneumonia, non infectious pneumonia requiring corticosteroid treatment, currently suffering from grade 2 or other types of pneumonia, or objective evidence of severe impairment of lung function confirmed by pulmonary function examination (FEV1 or DLCO or DLCO/VA accounting for% of expected value<40%).
Patients with active tuberculosis within one year prior to enrollment. k) Allergic constitution, or a history of severe allergies, or severe hypersensitivity reactions after receiving other monoclonal antibody treatments, or known allergies to the study drug excipients, or allergies to Tween 80.
Previous history of severe mental disorders. m) Individuals with a history of drug abuse, alcohol or drug abuse.
The end of previous clinical studies (last administration) is less than 4 weeks or the 5 half-lives of the study drug, whichever is shorter.
Vaccination history within the first 28 days of randomization or vaccination during the planned study period.
Pregnant or lactating female patients.
According to the researcher's viewpoint, it may increase the risk associated with participating in the study, or other reasons may make it unsuitable to participate in this clinical study.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kai Li, doctor contact

18622221218

likai@tjmuch.com

City, postcode or hospital

Sites recruiting now only

5 sites in 1 country

China5 sites, 5 recruiting

The Central People's Hospital of Huizhou
Huizhou, Guangdong, 516001
Hailin Xiong, Doctor, 15976198371, Jndx23207@126.com
Not yet recruiting
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222000
Cheng Chen, doctor, 15261349056, chenchenggood@163.com
Recruiting
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473000
Peng Cheng, Master, 13782042723, oncologist@163.com
Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Kai Li, doctor, 18622221218, likai@tjmuch.com
Jing Wang, doctor, 18622228650, wangjing_0220@163.com
Recruiting
Weihai Municipal Hospital
Weihai, Shandong, 264299
Fujun Yang, Doctor, 13181149906, 58500775@qq.com
Not yet recruiting

Other trials in China

About this study

Official title: Randomized, Double-blind, Parallel Controlled, Multicenter Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Arotinib Capsules and Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer After Immune Resistance

Conditions: Non-small-cell Lung Cancer
Being tested: TQB2450 +Anlotinib+Docetaxel, TQB2450 +Androtinib Placebo+Docetaxel
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

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

TQB2450 +Anlotinib+DocetaxelDrug
Also called TQB2450/Anlotinib/Docetaxel
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand 1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on the surface of T cells, restoring T cell activity and enhancing immune response. It has the potential to treat various types of tumors.
Anlotinib is a multi target receptor tyrosine kinase (RTK) inhibitor. It can inhibit VEGFR1, VEGFR2, VEGFR3, c-Kit, PDGFR β Activity.
Docetaxel is a taxane based anti-tumor drug.
TQB2450 +Androtinib Placebo+DocetaxelDrug
Also called TQB2450/Anlotinib Placebo/Docetaxel
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand 1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on the surface of T cells, restoring T cell activity and enhancing immune response. It has the potential to treat various types of tumors.
Androtinib Placebo Docetaxel is a taxane based anti-tumor drug.

Study groups in NCT06141226
Study group	Role	What they receive
TQB2450 +Anlotinib+Docetaxel	Experimental	TQB2450（1200mg intravenous(iv). 3 weeks using a(q3w), day 1(d1)）+Anlotinib administered PO at day 1-14 every 3 weeks+Docetaxel（60mg/square meter intravenous(iv). 3 weeks using a(q3w), day 1(d1)） Receives: Drug: TQB2450 +Anlotinib+Docetaxel
TQB2450 +Androtinib Placebo+Docetaxel	Placebo comparator	TQB2450 Injection（1200mg intravenous(iv). 3 weeks using a(q3w), day 1(d1)）+Anlotinib capsule placebo administered PO at day 1-14 every 3 weeks+Docetaxel Injection（60mg/square meter intravenous(iv),q3w, d1） Receives: Drug: TQB2450 +Androtinib Placebo+Docetaxel

What is being measured

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

Progression-Free Survival (PFS)
PFS will be defined as median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs first.
Measured: up to 48 weeks

Secondary outcomes (4)

Overall response rate (ORR)
Objective response rate refers to the percentage of complete response (CR) or partial response (PR) subjects determined by the investigator based on Response Evaluation Criteria in Solid Tumors(RECIST) 1.1 or modified RECIST1.1 for immune based therapeutics(iRECIST) (CR and PR under iRECIST criteria can occur after imaging disease progression).
Measured: up to 48 weeks
Disease control rate（DCR）
Disease control rate refers to the percentage of subjects with CR, PR, or stable disease (SD) of 6 weeks or more as determined by RECIST 1.1 or iRECIST (CR, PR, SD under iRECIST criteria can occur after imaging disease progression).
Measured: up to 48 weeks
Overall survival (OS)
Overall survival defined as the time from enrollment to death from any cause.
Measured: Baseline up to die
Duration of Response (DOR)
DOR will be defined as median number of months from date of first documented objective response until first documented sign of disease progression or death due to any causes.
Measured: up to 48 weeks

Timeline

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

12 Apr 202330 Dec 2028

First posted21 Nov 2023
Study start12 Apr 2023
Primary completion30 Dec 2027 (estimated)
Study completion30 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-small-cell Lung CancerStudies of the same condition, open and under way.
More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 148 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06141226
Sponsor's protocol ID: TQB2450-ALTN-II-02
Status last verified: Apr 2024
First submitted: 14 Nov 2023
Last updated: 19 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind, Parallel Controlled, Multicenter Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Arotinib Capsules and Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer After Immune Resistance
ClinicalTrials.gov ID: NCT06141226
Acronym / sponsor ID: TQB2450-ALTN-II-02
Conditions: Non-small-cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 148 participants (estimated)
Lead sponsor: Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
Study start: 12 Apr 2023 (actual)
Primary completion: 30 Dec 2027 (estimated)
Study completion: 30 Dec 2028 (estimated)
First posted: 21 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
TQB2450 +Anlotinib+Docetaxel	Experimental	Drug: TQB2450 +Anlotinib+DocetaxelTQB2450（1200mg intravenous(iv). 3 weeks using a(q3w), day 1(d1)）+Anlotinib administered PO at day 1-14 every 3 weeks+Docetaxel（60mg/square meter intravenous(iv). 3 weeks using a(q3w), day 1(d1)）
TQB2450 +Androtinib Placebo+Docetaxel	Placebo comparator	Drug: TQB2450 +Androtinib Placebo+DocetaxelTQB2450 Injection（1200mg intravenous(iv). 3 weeks using a(q3w), day 1(d1)）+Anlotinib capsule placebo administered PO at day 1-14 every 3 weeks+Docetaxel Injection（60mg/square meter intravenous(iv),q3w, d1）

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

According to the International Association for the Study of Lung Cancer and the Joint Committee on the American Classification of Cancer, 8th edition TNM staging of lung cancer, patients with locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) NSCLC who are histologically proven to be inoperable and unable to undergo radical synchronous radiotherapy and chemotherapy.
18 years old ≤ age ≤ 75 years old; No gender limit; ECOG score 0-1 points; The expected survival period is ≥ 3 months.
According to RECIST 1.1 standard, there should be at least one measurable lesion.
Tumor resistance has progressed after receiving first-line treatment with immune checkpoint inhibitors (including PD-1 or PD-L1 monoclonal or dual antibodies) combined with platinum based drugs in the past. For neoadjuvant/adjuvant chemotherapy or radiotherapy or concurrent radiotherapy and chemotherapy, if the disease progresses during treatment or within 6 months after discontinuation of treatment, it should be considered as a first-line treatment plan.
It is necessary to provide tumor tissue sections that have been diagnosed with advanced or metastatic NSCLC and have not undergone radiotherapy (at least 5 samples are required for PD-L1 testing of tumor tissue, but if testing has been conducted before the first line treatment, recognized test results from each participating center can be accepted.) Tumor tissue samples must be archived samples or freshly obtained samples within the first 12 months of randomization.

Key exclusion criteria (33 listed)

① Only supratentorial and cerebellar metastases are allowed (i.e. transfer to the midbrain, pons, medulla, or spinal cord is not allowed);
② No imaging evidence of new or enlarged brain metastases was found;
③ There are no symptoms of brain metastasis, and the subject must have stopped using corticosteroids/dehydrating agents for at least 2 weeks before starting to use the investigational drug.
④ Before starting to use the investigational drug, the subject must have stopped using corticosteroids/dehydrating agents for at least 2 weeks.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TQB2450 +Anlotinib+DocetaxelAlso: TQB2450/Anlotinib/DocetaxelTQB2450 is a humanized monoclonal antibody targeting programmed death ligand 1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on the surface of T cells, restoring T cell activity and enhancing immune response. It has the potential to treat various types of tumors. Anlotinib is a multi target receptor tyrosine kinase (RTK) inhibitor. It can inhibit VEGFR1, VEGFR2, VEGFR3, c-Kit, PDGFR β Activity. Docetaxel is a taxane based anti-tumor drug.	Drug	TQB2450 +Anlotinib+Docetaxel
TQB2450 +Androtinib Placebo+DocetaxelAlso: TQB2450/Anlotinib Placebo/DocetaxelTQB2450 is a humanized monoclonal antibody targeting programmed death ligand 1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on the surface of T cells, restoring T cell activity and enhancing immune response. It has the potential to treat various types of tumors. Androtinib Placebo Docetaxel is a taxane based anti-tumor drug.	Drug	TQB2450 +Androtinib Placebo+Docetaxel

Primary outcome

Progression-Free Survival (PFS)
Time frame: up to 48 weeks
PFS will be defined as median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs first.

4 secondary outcomes

Overall response rate (ORR)
Time frame: up to 48 weeks
Disease control rate（DCR）
Time frame: up to 48 weeks
Overall survival (OS)
Time frame: Baseline up to die
Duration of Response (DOR)
Time frame: up to 48 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Kai Li, doctor contact

18622221218

likai@tjmuch.com

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQB2450 +Anlotinib+Docetaxel in people with Non-small-cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 5 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 9 inclusion and 33 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Kai Li, doctor (18622221218, likai@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: up to 48 weeks). 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 NCT06141226.

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 19 Sep 2024.