Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer

CTTQ

Status and phase: Unknown; Phase 3

Conditions: Squamous Non-small Cell Lung Cancer

Treatments: Drug: Placebos; Drug: Anlotinib; Drug: Carboplatin; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04073537

ALTN-03-III-02

Details and patient eligibility

About

Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities.

Enrollment: 386 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Squamous non-small cell lung cancer.
2. A measurable lesion.
3. The disease progression occurs >12 months after the end of the last treatment. 4.18-75 years old ; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.

5.Adequate laboratory indicators. 6.No pregnant or breastfeeding women, and a negative pregnancy test. 7.Understood and signed an informed consent form.

Exclusion criteria

1. The tumor invades the large blood vessels.
2. Central type squamous non-small cell lung cancer.
3. EGFR/ALK gene mutation is positive.
4. Has used EGFR inhibitors and ALK inhibitors.
5. Has other malignant tumors within 5 years.
6. Has a variety of factors affecting oral medications.
7. Symptomatic brain metastasis.
8. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
9. Spinal cord compression.
10. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization.
11. Severe allergies to therapeutic medications.
12. Adverse events caused by previous treatment did not recover to grade 1.
13. Has received major surgical treatment within 4 weeks before randomization.
14. Arteriovenous thrombosis occurred within 6 months.
15. Has drug abuse history that unable to abstain from or mental disorders.
16. Has severe or uncontrolled disease.
17. Participated in other clinical trials within 4 weeks.
18. According to the investigators' judgement.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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386 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

Anlotinib hydrochloride capsules 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) and paclitaxel 175mg/m2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

Drug: Anlotinib

Placebo group

Placebo Comparator group

Description:

Anlotinib hydrochloride placebo 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) and paclitaxel 175mg/m\^2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.

Treatment:

Drug: Placebos

Drug: Carboplatin

Drug: Paclitaxel