Study of TQB2450 Combined With Anlotinib in the Treatment of Mutation Positive Lung Cancer

C

CTTQ

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Lung Cancer

Treatments

Drug: TQB2450
Drug: Anlotinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03983928
TQB2450-Ib-11

Details and patient eligibility

About

This is an open-label, single center, non-randomized, phase Ib trial to evaluate safety and efficacy of TQB2450 injection combined with anlotinib in patients with advanced mutation positive non-small cell lung cancer.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Understood and signed an informed consent form.
  • 18 years and older.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks.
  • Histologically or cytologically confirmed mutation positive non-small cell lung cancer according to 8th International Association for the Study of Lung Cancer (IASLC) edition.
  • Has measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Adequate organ system function, defined as follows:

  • absolute neutrophil count (ANC) ≥ 1.5×10^9/L, platelets (PLT) ≥ 100×10^9/L, hemoglobin (Hb)≥ 90g /L;
  • total bilirubin (TBIL) ≤ 1.5×ULN;alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN (without liver metastasis) or ≤ 5.0 × ULN (with liver metastasis), Creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 ml/min;
  • Urine protein < ++,or urine protein ≥ ++ concomitant with content of 24-hour urinary protein <1.0 g;
  • international normalized ratio (INR) ≤ 1.5×ULN, activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
  • left ventricular ejection fraction (LVEF) ≥ 50%;
  • Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.

Exclusion criteria

  • Has diagnosed and/or treated additional malignancy within 5 years prior to randomization except of cured in situ carcinoma of the cervix, non-melanoma skin cancer and superficial bladder carcinoma.
  • Has severe hypersensitivity reactions after taking other monoclonal antibodies.
  • Has hypersensitivity reactions after taking anlotinib.
  • Has prior therapy with anlotinib, anti-programmed cell death (PD)-1, anti-PD-L1 or other immunotherapy against PD-1/PD-L1.
  • Has any active autoimmune disease or history of autoimmune disease, such as autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis, asthma patients who need bronchiectasis for medical intervention; Subjects with the vitiligo without systemic treatment, psoriasis, alopecia, well-controlled type I diabetes mellitus, hypothyroidism stable on hormone replacement will not be excluded from this study.
  • Has multiple factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.
  • Has clinical significance of thyroid dysfunctions within 6 months prior to enrollment, and even though medical therapy, thyroid function can not return to normal or no clinical significance.
  • Has central nervous system (CNS) metastases without local therapy of lesion.
  • Radiograph (within 28 days before enrollment) showed that the tumor surrounded important blood vessels, and the investigators determined that entering the study would cause bleeding risk.
  • Hemoptysis (defined as coughing out or spitting out ≥ 1 teaspoon of blood or small blood clots or hemoptysis without sputum) within 28 days before enrollment , not including bloody sputum.
  • Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration.

Has any of the following severe acute complications:

  • Unstable angina and/or congestive heart failure or vascular disease requiring hospitalization within 12 months, or other cardiac impairments determined by the investigator, which may affect the evaluation of drug safety; Myocardial infarction or ischemia with ST elevation ≥ 2 mm indicated by electrocardiogram (ECG);
  • Has pulmonary infections and/or acute bacterial or fungal infections requiring intravenous antibiotic therapy;
  • Has clinical jaundice caused by liver dysfunction;

Virological test indicates one of the following items before enrollment:

  • HBsAg positive and HBV DNA ≥ 1 × 10^3 copies/mL;
  • Anti-HCV positive and HCV virus titer detection value exceeds the upper limit of normal value;
  • HIV positive;
  • Has participation in an anti-tumor clinical trial within 28 days prior to the first administration.
  • Has serious affecting safety or treatment compliance concomitant diseases, according to the investigator's judgment.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

TQB2450 Combined with Anlotinib
Experimental group
Description:
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib capsules 12 mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
Treatment:
Drug: Anlotinib
Drug: TQB2450

Trial contacts and locations

0

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Central trial contact

Li Zhang

Data sourced from clinicaltrials.gov

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