Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Death

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Apatinib

Pemetrexed

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Protein Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

Camrelizumab 200mg q2w ivgtt+ Apatinib Mesylate 250mg once daily po qd

For non-squamous NSCLC: Pemetrexed disodium for injection + Carboplatin; For squamous NSCLC: Paclitaxel injection + Carboplatin

Camrelizumab 200mg

Apatinib Mesylate 250mg

Pemetrexed disodium for injection 500 mg/m2 q3w

Pemetrexed disodium for injection

Paclitaxel injection

Quanren Wang, PhD

Weixia Li, Master

The study is being conducted to evaluate the efficacy and safety of Camrelizumab (200mg,q2w) combined with Apatinib(250mg qd) in subjects with PD-L1 positive relapsed or advanced non-small cell lung cancer.

Camrelizumab Combined With Apatinib Mesylate or Camrelizumab Alone for First-line Treatment in Subjects With Programmed Death Ligand 1 (PD-L1) Positive Relapsed or Advanced Non-small Cell Lung Cancer (NSCLC)

A Randomized, Open-Label, Controlled, Multicenter Phase III Study of Camrelizumab Combined With Apatinib Mesylate or Camrelizumab Alone Versus Platinum-based Chemotherapy for First-line Treatment in Subjects With PD-L1 Positive Relapsed or Advanced NSCLC

Progression Free Survival, defined as the time from randomization to the first occurrence of disease progression as determined by IRC with use of Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death from any cause, whichever occurs first.

Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up

Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points

Disease Control Rate, determined using RECIST v1.1 criteria

Duration of Response, determined using RECIST v1.1 criteria

Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.

Adverse Events and Serious Adverse Events

Jiangsu HengRui Medicine Co., Ltd.

Amino Acids

Antibodies

Antibodies, Monoclonal

Cisplatin

Immunoglobulins

Tyrosine

TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle.

TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle. Pemetrexed disodium for injection, 21 days as a treatment cycle. Cisplatin injection, 21 days as a treatment cycle.

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1).

TQB2450 injection

AL2846 is a multi-targeted tyrosine kinase receptor inhibitor

AL2846 capsule

Pemetrexed disodium is a multi-target antifolate antineoplastic drug.

Cisplatin injection

This is a Phase Ib clinical trial to evaluate the safety and efficacy of TQB2450 injection combined with AL2846 capsules in patients with advanced solid tumors.

A Clinical Trial of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors

A Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors

Proportion of subjects achieving complete and partial response

The proportion of subjects with adverse events (AE), severe adverse events (SAE) and abnormal laboratory examination indicators

The severity of adverse events (AE), severe adverse events (SAE) and abnormal laboratory examination indicators assessed by Common Terminology Criteria For Adverse Events (CTCAE) 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Camrelizumab Combined With Apatinib Mesylate or Camrelizumab Alone for First-line Treatment in Subjects With Programmed Death Ligand 1 (PD-L1) Positive Relapsed or Advanced Non-small Cell Lung Cancer (NSCLC)	NCT04203485	PD-L1 Positive ...	Camrelizumab 20... Apatinib Mesyla... Pemetrexed diso... Paclitaxel inje... Carboplatin	18 Years - 70 Years	Jiangsu HengRui Medicine Co., Ltd.
A Clinical Trial of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors	NCT06116240	Solid Tumor	TQB2450 injecti... AL2846 capsule Pemetrexed diso... Cisplatin injec...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Trial of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors	NCT06116240	Solid Tumor	TQB2450 injecti... AL2846 capsule Pemetrexed diso... Cisplatin injec...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for pemetrexed disodium for injection