Advanced Non-squamous NSCLCPhase 4NCT03768037
Anlotinib Plus Pemetrexed or Pemetrexed for Previously Untreated Elderly (>=70) or PS=2 Non-squamous NSCLC
A Phase 4 study testing Anlotinib plus Pemetrexed and Pemetrexed in people with Advanced Non-squamous NSCLC, run by Guangdong Association of Clinical Trials at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Advanced Non-squamous NSCLC
- What is being tested?
- Anlotinib plus Pemetrexed and Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2018to 26 Nov 2020
- Phase
- Phase 4
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chest Hospital
Beijing, Beijing Municipality, 101149
Shucai Zhang, 86-010-89509324, sczhang6304@163.com
Zhe Liu, 86-010-89509323, liuzhe1968@aliyun.com
About this study
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.
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.
Read the detailed description
Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.
- Conditions
- Advanced Non-squamous NSCLC
- Being tested
- Anlotinib plus Pemetrexed, Pemetrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib plus PemetrexedDrug
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
PemetrexedDrug
Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib plus Pemetrexed | Experimental | Anlotinib plus Pemetrexed Receives: Drug: Anlotinib plus Pemetrexed |
| Pemetrexed | Other | Pemetrexed Receives: Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients alive and progression free at 6 months (APF6)
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.
Measured: Estimated to be from baseline up to 2 years
Secondary outcomes (4)
Progression Free Survival(PFS)
the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Measured: Estimated to be from baseline up to 2 years
Overall Survival(OS)
the time from randomization to death from any cause
Measured: Estimated to be from baseline up to 2 years
Disease Control Rate(DCR)
the total proportion of patients who demonstrate a response(complete responses + partial responses + stable disease ) to treatment
Measured: Estimated to be from baseline up to 2 years
Objective Response Rate(ORR)
the total proportion of patients who demonstrate a response(complete responses + partial responses) to treatment
Measured: Estimated to be from baseline 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.
- First posted7 Dec 2018
- Study start26 Nov 2018 (estimated)
- Primary completion26 Nov 2019 (estimated)
- Study completion26 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-squamous NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768037
- Sponsor's protocol ID
- CTONG1801
- Status last verified
- Nov 2018
- First submitted
- 30 Nov 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03768037
- Acronym / sponsor ID
- CTONG1801
- Conditions
- Advanced Non-squamous NSCLC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- 26 Nov 2018 (estimated)
- Primary completion
- 26 Nov 2019 (estimated)
- Study completion
- 26 Nov 2020 (estimated)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib plus Pemetrexed | Experimental | Drug: Anlotinib plus PemetrexedAnlotinib plus Pemetrexed |
| Pemetrexed | Other | Drug: PemetrexedPemetrexed |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anlotinib plus PemetrexedAnlotinib 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 | Drug | Anlotinib plus Pemetrexed |
| PemetrexedPemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects | Drug | Pemetrexed |
Primary outcome
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.
4 secondary outcomes
Progression Free Survival(PFS)
Time frame: Estimated to be from baseline up to 2 years
Overall Survival(OS)
Time frame: Estimated to be from baseline up to 2 years
Disease Control Rate(DCR)
Time frame: Estimated to be from baseline up to 2 years
Objective Response Rate(ORR)
Time frame: Estimated to be from baseline up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anlotinib plus Pemetrexed and Pemetrexed in people with Advanced Non-squamous NSCLC, run by Guangdong Association of Clinical Trials 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 5 inclusion and 4 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 7 Dec 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Xiaoqing Liu (86-010-89509324, liuxiaoqing@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients alive and progression free at 6 months (APF6) (time frame: Estimated to be from baseline up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2018.