Anlotinib Plus Pemetrexed or Pemetrexed for Previously Untreated Elderly (>=70) or PS=2 Non-squamous NSCLC
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ClinicalTrials.gov Identifier: NCT03768037 |
Recruitment Status : Unknown
Verified November 2018 by Guangdong Association of Clinical Trials.
Recruitment status was: Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Non-squamous NSCLC | Drug: Anlotinib plus Pemetrexed Drug: Pemetrexed | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 106 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Study to Evaluate the Efficacy and Safety of Anlotinib Plus Pemetrexed as the 1-line Treatment of Patients With Platinum Intolerant Advanced Non-squamous NSCLC, With Pemetrexed Control. |
Estimated Study Start Date : | November 26, 2018 |
Estimated Primary Completion Date : | November 26, 2019 |
Estimated Study Completion Date : | November 26, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Anlotinib plus Pemetrexed
Anlotinib plus Pemetrexed
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Drug: Anlotinib plus Pemetrexed
Anlotinib p.o, qd and it should be continued until disease progress or unacceptable toxic effects. Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects |
Pemetrexed
Pemetrexed
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Drug: Pemetrexed
Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects |
- Proportion of patients alive and progression free at 6 months (APF6) [ Time Frame: Estimated to be from baseline up to 2 years ]the number (%) of patients who are alive and progression free per RECIST 1.1 at 6 months after randomization per Kaplan-Meier estimate of progression free survival at 6 months.
- Progression Free Survival(PFS) [ Time Frame: Estimated to be from baseline up to 2 years ]the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
- Overall Survival(OS) [ Time Frame: Estimated to be from baseline up to 2 years ]the time from randomization to death from any cause
- Disease Control Rate(DCR) [ Time Frame: Estimated to be from baseline up to 2 years ]the total proportion of patients who demonstrate a response(complete responses + partial responses + stable disease ) to treatment
- Objective Response Rate(ORR) [ Time Frame: Estimated to be from baseline up to 2 years ]the total proportion of patients who demonstrate a response(complete responses + partial responses) to treatment

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Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥70 years old and ECOG PS=0-2 or ≥18 years old and ECOG PS=2
- Diagnosed with advanced or recurrent non-squamous NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1)
- No prior systemic treatment for non-squamous NSCLC
- Negative in EGFR&ALK&ROS1
- Main organs function is normal
Exclusion Criteria:
- Have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding
- Symptoms of brain metastases cannot be controlled and treated within less than 21 days
- Have participated in other clinical trials of anti-tumor medicine within 4 weeks
- Get any severe diseases or the ones that cannot be controlled

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768037
Contact: Xiaoqing Liu | 86-010-89509324 | liuxiaoqing@csco.org.cn | |
Contact: Shucai Zhang | 86-010-89509324 | sczhang6304@163.com |
China, Beijing | |
Beijing Chest Hospital | Recruiting |
Beijing, Beijing, China, 101149 | |
Contact: Shucai Zhang 86-010-89509324 sczhang6304@163.com | |
Contact: Zhe Liu 86-010-89509323 liuzhe1968@aliyun.com |
Responsible Party: | Guangdong Association of Clinical Trials |
ClinicalTrials.gov Identifier: | NCT03768037 |
Other Study ID Numbers: |
CTONG1801 |
First Posted: | December 7, 2018 Key Record Dates |
Last Update Posted: | December 7, 2018 |
Last Verified: | November 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |