AzTrials
AzTrials

Advanced Non-squamous Non-small Cell Lung CancerPhase 3NCT05346952

A Study of TQB2450 Injection Plus Chemotherapy Followed by TQB2450 Plus Anlotinib Versus Tislelizumab Plus Chemotherapy Followed by Tislelizumab in the Treatment of First-line Non-squamous Non-small Cell Lung Cancer(NSCLC).

A Phase 3 study testing TQB2450 injection, Tilelizumab injection, Anlotinib hydrochloride capsule, Pemetrexed disodium injection, Carboplatin injection in people with Advanced Non-squamous Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is Phase 3, randomized, open-label, parallel controlled study designed to compare the efficacy and safety of TQB2450 in combination with platinum-containing chemotherapy followed by TQB2450 plus Anlotinib versus tislelizumab in combination with platinum-containing chemotherapy followed by tislelizumab in locally… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
TQB2450 injection, Tilelizumab injection, Anlotinib hydrochloride capsule, Pemetrexed disodium injection, Carboplatin injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
390 participants
Where
1 siteChina
Study dates
25 Jan 2022to Dec 2023
Phase
Phase 3
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

  • 1 According to the 8th edition of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification, the TNM staging of lung cancer is locally advanced (stage ⅢB/ⅢC), metastatic or recurrent ( Stage IV) NSCLC patients.
  • 2 Between the ages of 18-75 years (calculated based on the date of signing ICF); male or female; Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥ 3 months.
  • 3 According to the RECIST 1.1 standard, there is at least one measurable lesion. If the measurable lesion is located in the radiotherapy area, it should be clearly defined as a progressive state.
  • 4 Patients who have not received systemic anti-tumor therapy for advanced, recurrent or metastatic diseases in the past. For those who have received adjuvant chemotherapy in the past, the interval between the recurrence time and the last adjuvant chemotherapy should be at least 6 months; The interval between the end of previous radiotherapy for chest and this treatment should be more than 6 months, and the interval between palliative radiotherapy for chest and this treatment should be more than 7 days.
  • 5 Tumor tissue sections that have not undergone radiotherapy at or after the diagnosis of advanced or metastatic NSCLC must be provided. Tumor tissue samples must be archived samples or freshly obtained samples within 12 months before randomization.
  • 6 For non-squamous NSCLC, patients with no EGFR sensitive mutations, ALK fusion, ROS1 fusion
Show all 14Show fewer
  • 7 The function of main organs are well and meet the following standards:
  • 8 a. Routine blood examination standards (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days before screening): i. Absolute neutrophil count (ANC) ≥1.5×109 /L; ii. Platelets ≥100×109 /L; iii. Hemoglobin ≥90 g/L. b. The blood biochemical examination shall meet the following standards: i. Total bilirubin (TBIL) ≤ 2 × upper limit of normal (ULN) (Patients with Gilbert syndrome ≤ 3 × ULN); ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN. If it is accompanied by liver metastasis, ALT and AST≤5×ULN; 8.iii. Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance estimated by Cockcroft-Gault glomerular filtration formula ≥60 mL/min; iv. Serum albumin (ALB) ≥30g/L. c. Urine routine examination standard: urine routine indicates urine protein <++; if urine protein ≥++, it is necessary to confirm that the 24-hour urine protein quantitative ≤1.0 g.
  • Blood coagulation test standards: prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR)≤1.5×ULN (no anticoagulant therapy).
  • Thyroid Stimulating Hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be examined. If T3 and T4 levels are normal, it can be selected.
  • Heart color Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%.
  • 12-lead ECG evaluation: QTc<450ms (male), QTc<470ms (female).
  • 9 Women of childbearing age should agree to use effective contraceptive measures during the study period and 6 months after the end of the study, and have a negative serum pregnancy test within 7 days before the study enrollment; men should agree to the study period and 6 months after the end of the study period Effective contraceptive measures must be used internally.
  • 10 The subjects voluntarily joined the study, signed the informed consent form, and had good compliance.

Who cannot join

  • 1 Tumor disease and medical history:
  • Brain metastases without local treatment; Note: Subjects who have previously received brain metastasis therapy and meet all the following criteria can participate in this study: i. Only supratentorial and cerebellar metastases; ii. The condition needs to be stable for ≥4 weeks and no new brain metastases or brain metastases are found Expanded imaging evidence; iii. The subject must have stopped corticosteroids/dehydrator for at least 2 weeks before starting to use the trial drug;
  • There are midbrain, pons, medulla oblongata, spinal cord and meningeal metastases；
  • Other malignant tumors appeared or were present within 3 years. The following two cases can be included: other malignant tumors treated by single operation have achieved 5-year Disease-free survival (DFS) in a row; The cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor [ta (non-invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
  • Central type, cavity squamous cell carcinoma (primarily in the main bronchus and around the hilar);Imaging shows that the tumor invades large blood vessels or is unclearly separated from the blood vessels, or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the subsequent study(The major vessels in the chest include pulmonary aorta, left pulmonary artery, right pulmonary artery, four pulmonary veins, superior vena cava, inferior vena cava and aorta);
  • Severe bone injury caused by tumor bone metastasis, including pathological fracture of weight-bearing bone and spinal cord compression that occurred within 6 months or is expected to occur in the near future(Such as spine, pelvis, femur, tibia, phalanges, calcaneus, etc.);
Show all 27Show fewer
  • Patients with serous cavity (thoracic cavity, abdominal cavity, or pericardial cavity) that require repeated drainage to relieve clinical symptoms (as determined by the investigator), or who have received drainage of serous cavity effusion for the purpose of treatment within 2 weeks before treatment.
  • 2 Previous anti-tumor treatments:
  • Received the treatment of proprietary Chinese medicines with anti-tumor indications specified in the NMPA approved drug instructions within 2 weeks before the start of the study treatment(Including compound cantharidin capsules, Kangai injection, Kanglaite capsule/injection, Aidi injection, brucea javanica oil injection/capsule, Xiaoaiping tablet/injection, Huachansu capsule, etc.);
  • Previously received related immunotherapy drugs for programmed death 1 (PD-1), PD-L1, cytolytic T lymphocyte-associated antigen-4 (CTLA-4), etc.;
  • Previous use of anti-angiogenic drugs such as bevacizumab, anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, regorafenib, fruquintinib, etc.;
  • Patients who have been vaccinated with immunomodulatory drugs within 30 days before starting treatment(Such as interleukin-2, thymosin, lentinan, etc.);
  • Failure to recover from the toxicity and/or complications of previous interventions to CTCAE ≤1, except for hair loss and peripheral neuropathy ≤2;
  • 3 Combined diseases and medical history:
  • Liver cirrhosis, active hepatitis*;(Note: active hepatitis (hepatitis B reference: HBV-DNA > 1*103 copy /mL or > 2000IU/mL) when HBsAg is positive. Hepatitis C reference: HCV antibody is positive, and HCV titer detection value exceeds the upper limit of normal value);
  • Renal abnormalities: i.Renal failure requires hemodialysis or peritoneal dialysis; ii.Previous or existing nephrotic syndrome, chronic nephritis.
  • Cardiovascular and cerebrovascular abnormalities： i.Patients with previous or present heart failure, degree II or above heart block: ii.Myocardial infarction or unstable angina, supraventricular or ventricular arrhythmia with clinical significance need treatment or intervention; iii.Vascular embolism and cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage and cerebral infarction) occurred within 9 months（ Prophylactic use of anticoagulant therapy is allowed for patients with thrombotic tendency or undergoing anticoagulant therapy.) iv.After more than two kinds of drug treatment, blood pressure control is still not ideal (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg).
  • Gastrointestinal abnormalities: i.Inability to take medications (such as inability to swallow, intestinal obstruction, etc.); ii.A history of malabsorption syndrome or other diseases that interfere with gastrointestinal absorption; iii.Received treatment for active peptic ulcer in the past 6 months; iv.Despite the maximum medical treatment, chronic diarrhea of grade 2 and above continues to occur; v.Other conditions determined by the researcher that may cause gastrointestinal bleeding and perforation.
  • History of immunodeficiency:
  • i.Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases; ii.Active autoimmune disease or history of autoimmune disease, including but not limited to Crohn's disease, ulcerative colitis, autoimmune hepatitis/enteritis/vasculitis/nephritis, etc.
  • iii.Prepare to undergo or have previously received an organ transplant; iv.Patients who require systemic or topical immunosuppressive therapy to achieve immunosuppressive purposes and need to continue to use them within two weeks before randomization (except for glucocorticoid daily dose <10 mg prednisone or other equivalent hormones).
  • Note: Hormone replacement therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered as systemic therapy and allowed to be used.
  • Bleeding risk: i.Suffered from bleeding or coagulopathy within 28 days before the start of treatment or was using warfarin, aspirin and other antiplatelet agglutination drugs (except for aspirin ≤100 mg/d preventive drugs); ii.Had hemoptysis >2.5 mL/day in 28 days before the start of treatment; iii.Regardless of the severity, patients with any history of bleeding or coagulopathy; iv.Received major surgical treatment, open biopsy, etc. within 28 days before the start of the study treatment; v.Long-term unhealed wounds or fractures, except for pathological fractures; g. Poor control of type I diabetes or II diabetes (fasting blood glucose (FBG)> 10mmol/L); h. Severe infections within 4 weeks before the start of study treatment, including but not limited to hospitalization due to bacteremia, severe pneumonia, or other severe infections; subjects with ≥ grade 2 active infections within 4 weeks before the start of study treatment Or fever of unknown cause occurred during the screening period and before the first administration>38.0℃; i. Past or existing pneumoconiosis, interstitial pneumonia, (non-infectious) pneumonia that requires adrenal corticosteroid therapy, currently suffering from other types of pneumonia ≥2, or lung function tests confirmed severely impaired lung function (Forced Expiratory Volume in the first second (FEV1) or diffusing capacity of lung for carbon monoxide(DLCO) or DLCO per alveolar volume (DLCO /VA) accounts for the expected value %<40%) and other objective evidence; j. Patients with active tuberculosis within 1 year before enrollment; subjects with a history of active pulmonary tuberculosis infection 1 year ago must provide clear evidence of cure before enrollment; if tuberculosis is suspected during the screening period, chest radiographs and sputum must be passed Enter the group only after the liquid and clinical symptoms are eliminated; k. Allergies, or a history of severe allergies in the past, or severe hypersensitivity reactions after receiving other monoclonal antibody treatments, or known allergies to the ingredients of the study drug excipients; l. Previous history of severe mental disorders; m. People with a history of drug abuse, alcohol or drug abuse;
  • 4 The end of the previous clinical study (last dose) is less than 4 weeks or the study drug's 5 half-lives, whichever is shorter.
  • 5 Live attenuated vaccine vaccination history within 28 days before randomization or planned live attenuated vaccination during the study period. Seasonal influenza vaccine for injection is usually an inactivated virus vaccine and is allowed to be vaccinated during the study period.
  • 6 Female patients during pregnancy or lactation.
  • 7 According to the investigator's point of view, it may increase the risks associated with participating in the study, or other severe, acute or chronic medical diseases or laboratory abnormalities that may interfere with the interpretation of the study results, or other reasons that are not suitable for participating in this clinical study.

Trial locations and contacts

1 site in 1 country.

Yuankai Shi, Doctor contact

13701251865

syuankaipumc@126.com

China1 site, 1 recruiting

  • Chinese Academy of Medical Sciences Cancer Hospital

    Beijing, Beijing Municipality, 100021

    Yuankai Shi, Doctor, 13701251865, syuankaipumc@126.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 3，Randomized，Open，Parallel Controlled, Multi-center Study of TQB2450 Injection Plus Chemotherapy Followed by TQB2450 Plus Anlotinib Versus Tislelizumab Plus Chemotherapy Followed by Tislelizumab as a First-line Treatment on Patient With Advanced Non-squamous NSCLC

This is Phase 3, randomized, open-label, parallel controlled study designed to compare the efficacy and safety of TQB2450 in combination with platinum-containing chemotherapy followed by TQB2450 plus Anlotinib versus tislelizumab in combination with platinum-containing chemotherapy followed by tislelizumab in locally advanced (stage ⅢB/ⅢC), metastatic or recurrent ( Stage IV) non-squamous NSCLC cancer. The primary endpoint is Progression Free Survival (PFS) assessed by IRC.

Being tested
TQB2450 injection, Tilelizumab injection, Anlotinib hydrochloride capsule, Pemetrexed disodium injection, Carboplatin injection

What participants receive

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

  • TQB2450 injection, Tilelizumab injection, Anlotinib hydrochloride capsule, Pemetrexed disodium injection, Carboplatin injectionDrug

    PD-L1(programmed cell death-Ligand 1) may be expressed on tumor cells and/or tumor-infiltrating immune cells, which can inhibit the anti-tumor immune response in the tumor microenvironment. On T cells and antigen-presenting cells, PD-L1 binding to PD-1 (programmed cell death-1) and B7.1 receptors inhibits cytotoxic T cell activation, T cell proliferation, and cytokine production.

Study groups in NCT05346952
Study groupRoleWhat they receive
TQB2450 injection + carboplatin + pemetrexedExperimentalTQB2450 injection：1200 mg, Intravenous drip d1； carboplatin ：Area Under Curve 5mg/mL/min，Intravenous drip d1；Pemetrexed: 500mg/m2，Intravenous drip d1.The above schemes are repeated every three weeks. After 4 cycles, the regimen is changed to TQB2450 injection（1200 mg, Intravenous drip d1）+Pemetrexed（500mg/m2，Intravenous drip d1）+ Anlotinib (10mg, peros every day, d1-14) . The regimen is repeated every 3 weeks until the disease progresses.
Receives: Drug: TQB2450 injection, Tilelizumab injection, Anlotinib hydrochloride capsule, Pemetrexed disodium injection, Carboplatin injection
TQB2450 injection + Anlotinib + PemetrexedActive comparatorTilelizumab: 200 mg, Intravenous drip d1;carboplatin : AUC 5mg/mL/min, Intravenous drip d1；Pemetrexed: 500mg/m2, Intravenous drip d1.The above schemes are repeated every three weeks. After 4 cycles, the regimen is changed to Tilelizumab (200 mg, Intravenous drip d1)+Pemetrexed (500mg/m2，Intravenous drip d1).The regimen is repeated every 3 weeks until the disease progresses.
Receives: Drug: TQB2450 injection, Tilelizumab injection, Anlotinib hydrochloride capsule, Pemetrexed disodium injection, Carboplatin injection

What is being measured

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

  1. Progression Free Survival (PFS) assessed by IRC

    The period from the first use of the drug to disease progression or death (whichever occurs first).

    Measured: Up to 2 years

  2. Overall survival (OS)

    Time from randomization to death

    Measured: Up to 3 years

  3. According to response evaluation criteria in solid tumours 1.1（RECIST1.1）standard and iRECIST （Immune-related response evaluation criteria in solid tumours ）standard researcher's assessment of progression-free survival (PFS)

    The period from the first use of the drug to disease progression or death (whichever occurs first).

    Measured: Up to 2 years

  4. Objective Response Rate (ORR)

    Proportion of patients whose tumor volume shrinks to a predetermined value and maintains the minimum time limit

    Measured: Up to 2 years

  5. Disease Control Rate (DCR）

    Proportion of subjects whose tumors shrink or remain stable for a certain period, including CR, PR and stable disease SD

    Measured: Up to 2 years

  6. Duration of Remission (DOR)

    The period from firstly-recorded objective tumor response (CR or PR) to firstly-recorded objective tumor progression or death due to any cause (whichever occurs first) .

    Measured: Up to 2 years

  7. TTR

    Time from randomization to onset of remission (PR)

    Measured: Up to 2 years

Secondary outcomes (1)

  1. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)，as well as abnormal laboratory examination indicators.

    The proportion of AEs and SAEs recorded afte signing the informed consent form(ICF).

    Measured: Up to 2 years

Timeline

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

  1. First posted26 Apr 2022
  2. Study start25 Jan 2022
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
390 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05346952
Sponsor's protocol ID
TQB2450-Ⅲ-11
Status last verified
Apr 2022
First submitted
20 Apr 2022
Last updated
26 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TQB2450 injection, Tilelizumab injection, Anlotinib hydrochloride capsule, Pemetrexed disodium injection, Carboplatin injection in people with Advanced Non-squamous Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site 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 14 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Yuankai Shi, Doctor (13701251865, syuankaipumc@126.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) assessed by IRC (time frame: Up to 2 years). The study lists 7 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 NCT05346952.

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 26 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in