NSCLCPhase 1/2NCT03636685
Study of Anlotinib Plus Chemotherapy as the First-line Treatment in Patients With Advanced NSCLC
A Phase 1/2 study testing Anlotinib combined with pemetrexed and carboplatin, phase I, Anlotinib combined with paclitaxel and carboplatin, phase I and Anlotinib combined with pemetrexed and carboplatin, phase II in people with NSCLC and Adenocarcinoma, run by Chinese Academy of Medical Sciences.
Trial summary
Non-small cell lung cancer has the highest morbidity and mortality in China，and platinum-based chemotherapy is the standard first-line treatment for the wild-type NSCLC,however the overall survival still less than one year.Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NSCLC, Adenocarcinoma, Squamous Cell Carcinoma
- What is being tested?
- Anlotinib combined with pemetrexed and carboplatin, phase I, Anlotinib combined with paclitaxel and carboplatin, phase I and Anlotinib combined with pemetrexed and carboplatin, phase II
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2018to 14 Aug 2020
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age：18~70 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2
- Subjects with histologically or cytologically confirmed locally advanced or advanced NSCLC
- EGFR\ALK\ROS1 wildtype or unknown,or patients with EGFR\ALK\ROS1 mutations but refuse to receive corresponding inhibitors' treatment
- No indications for radiation therapy
- Previously chemotherapy naive or postoperative adjuvant chemotherapy ended more than 1 year
- Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which is confirmed by computed tomography (CT) scan or MRI
Who cannot join
- Small Cell Lung Cancer
- central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (>50ml/day)
- Within 30 days before enrollment, the patient had used any chemotherapy drugs in the previous treatment regimen or clinical study; Or, within 14 days before the first administration of the study therapy, the patient has used any targeted anticancer drugs in the previous treatment regimen or clinical study; Or stop other experimental drugs or cancer drugs for less than five half-life of the drug
- Previous use of anti-angiogenic drugs (such as anlotinib, apatinib, bevacizumab, endostar, etc.)
- have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
- Spinal cord compression or symptomatic and untreated brain metastases (asymptomatic, stable, no need for steroid treatment for 4 weeks before study start)
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- with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
- Previous histories include: interstitial pneumonia, drug-induced interstitial pneumonia, radiation pneumonia requiring steroid treatment, and clinically proven active interstitial pneumonia
- get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), prevenous thrombosis, and pulmonary embolism
- Have suffered from hemorrhagic disease or coagulation dysfunction
- diagnosed with disease which will severely endanger the security of patients or influence the completion of this research
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I/II Study of Anlotinib Combined With Platinum-based Chemotherapy as the First-line Treatment of Patients With Locally Advanced or Advanced Non-Small Cell Lung Cancer
Non-small cell lung cancer has the highest morbidity and mortality in China，and platinum-based chemotherapy is the standard first-line treatment for the wild-type NSCLC,however the overall survival still less than one year.Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit, which has strong effect of anti-angiogenesis.This study is aim to evaluate the efficacy and safety of the combination regimen of anlotinib plus platinum-based chemotherapy as first-line treatment for NSCLC.
- Conditions
- NSCLC, Adenocarcinoma, Squamous Cell Carcinoma
- Being tested
- Anlotinib combined with pemetrexed and carboplatin, phase I, Anlotinib combined with paclitaxel and carboplatin, phase I, Anlotinib combined with pemetrexed and carboplatin, phase II, Anlotinib combined with paclitaxel and carboplatin, phase II
- Keywords
- Anlotinib, NSCLC, platinum-based chemotherapy
- Medical subject headings
- Adenocarcinoma, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib combined with pemetrexed and carboplatin, phase IDrug
Also called APC I
Non-squamous cell lung cancer, Anlotinib Plus PC
This study will include a sequential evaluation of 3 subjects per dose group. low-dose groups: Anlotinib 8mg per day plus pemetrexed and carboplatin. middle-dose groups: Anlotinib 10mg per day plus pemetrexed and carboplatin. high-dose groups: Anlotinib 12mg per day plus pemetrexed and carboplatin to determine the appropriate dose of anlotinib in combination with paclitaxel and carboplatin
Anlotinib combined with paclitaxel and carboplatin, phase IDrug
Also called ATC I
Squamous cell lung cancer, Anlotinib plus TC
This study will include a sequential evaluation of 3 subjects per dose group. low-dose groups: Anlotinib 8mg per day plus paclitaxel and carboplatin. middle-dose groups: Anlotinib 10mg per day plus paclitaxel and carboplatin. high-dose groups: Anlotinib 12mg per day plus paclitaxel and carboplatin to determine the appropriate dose of anlotinib in combination with paclitaxel and carboplatin
Anlotinib combined with pemetrexed and carboplatin, phase IIDrug
Also called APCII
Anlotinib: established dose QD PO d1-14, pemetrexed,carboplatin, 21 days per cycle after 4-6 cycles, Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
Anlotinib combined with paclitaxel and carboplatin, phase IIDrug
Also called ATCII
Anlotinib :established dose QD PO d1-14, paclitaxel,carboplatin, 21 days per cycle
after 4-6 cycles, Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
| Study group | Role | What they receive |
|---|---|---|
| Non-squamous cell lung cancer | Experimental | Anlotinib combined with pemetrexed and carboplatin, phase I
Anlotinib combined with pemetrexed and carboplatin, phase II Receives: Drug: Anlotinib combined with pemetrexed and carboplatin, phase I; Drug: Anlotinib combined with pemetrexed and carboplatin, phase II |
| Squamous cell lung cancer | Experimental | Anlotinib combined with paclitaxel and carboplatin, phase I
Anlotinib combined with paclitaxel and carboplatin, phase II Receives: Drug: Anlotinib combined with paclitaxel and carboplatin, phase I; Drug: Anlotinib combined with paclitaxel and carboplatin, phase II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress free survival (PFS)
progression free survival
Measured: From date of enrollment until the date of first documented progression or date of death from any cause,whichever came first.up to 12 months
Secondary outcomes (4)
Objective Response Rate (ORR)
Objective Response Rate
Measured: each 21 days up to the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
Disease Control Rate
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Overall Survival (OS)
Overall survival
Measured: From enrollment until death (up to 36 months)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (Safety)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Time Frame: each 21 days up to the toxicity or PD (up to 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start15 Aug 2018 (estimated)
- Primary completion14 Aug 2019 (estimated)
- Study completion14 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Yuankai, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636685
- Sponsor's protocol ID
- NCC201807006
- Status last verified
- Aug 2018
- First submitted
- 13 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Han B, Li K, Zhao Y, Li B, Cheng Y, Zhou J, Lu Y, Shi Y, Wang Z, Jiang L, Luo Y, Zhang Y, Huang C, Li Q, Wu G. Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302). Br J Cancer. 2018 Mar 6;118(5):654-661. doi: 10.1038/bjc.2017.478. Epub 2018 Feb 13.
PubMed 29438373
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Anlotinib Combined With Platinum-based Chemotherapy as the First-line Treatment of Patients With Locally Advanced or Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03636685
- Acronym / sponsor ID
- NCC201807006
- Conditions
- NSCLC, Adenocarcinoma, Squamous Cell Carcinoma
- Keywords
- Anlotinib, NSCLC, platinum-based chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 Aug 2018 (estimated)
- Primary completion
- 14 Aug 2019 (estimated)
- Study completion
- 14 Aug 2020 (estimated)
- First posted
- 17 Aug 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.
Non-small cell lung cancer has the highest morbidity and mortality in China，and platinum-based chemotherapy is the standard first-line treatment for the wild-type NSCLC,however the overall survival still less than one year.Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit, which has strong effect of anti-angiogenesis.This study is aim to evaluate the efficacy and safety of the combination regimen of anlotinib plus platinum-based chemotherapy as first-line treatment for NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-squamous cell lung cancer | Experimental | Drug: Anlotinib combined with pemetrexed and carboplatin, phase I, Drug: Anlotinib combined with pemetrexed and carboplatin, phase IIAnlotinib combined with pemetrexed and carboplatin, phase I Anlotinib combined with pemetrexed and carboplatin, phase II |
| Squamous cell lung cancer | Experimental | Drug: Anlotinib combined with paclitaxel and carboplatin, phase I, Drug: Anlotinib combined with paclitaxel and carboplatin, phase IIAnlotinib combined with paclitaxel and carboplatin, phase I Anlotinib combined with paclitaxel and carboplatin, phase II |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age：18~70 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2
- Subjects with histologically or cytologically confirmed locally advanced or advanced NSCLC
- EGFR\ALK\ROS1 wildtype or unknown,or patients with EGFR\ALK\ROS1 mutations but refuse to receive corresponding inhibitors' treatment
- No indications for radiation therapy
Key exclusion criteria (11 listed)
- Small Cell Lung Cancer
- central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (>50ml/day)
- Within 30 days before enrollment, the patient had used any chemotherapy drugs in the previous treatment regimen or clinical study; Or, within 14 days before the first administration of the study therapy, the patient has used any targeted anticancer drugs in the previous treatment regimen or clinical study; Or stop other experimental drugs or cancer drugs for less than five half-life of the drug
- Previous use of anti-angiogenic drugs (such as anlotinib, apatinib, bevacizumab, endostar, etc.)
- have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
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 combined with pemetrexed and carboplatin, phase IAlso: APC INon-squamous cell lung cancer, Anlotinib Plus PC This study will include a sequential evaluation of 3 subjects per dose group. low-dose groups: Anlotinib 8mg per day plus pemetrexed and carboplatin. middle-dose groups: Anlotinib 10mg per day plus pemetrexed and carboplatin. high-dose groups: Anlotinib 12mg per day plus pemetrexed and carboplatin to determine the appropriate dose of anlotinib in combination with paclitaxel and carboplatin | Drug | Non-squamous cell lung cancer |
| Anlotinib combined with paclitaxel and carboplatin, phase IAlso: ATC ISquamous cell lung cancer, Anlotinib plus TC This study will include a sequential evaluation of 3 subjects per dose group. low-dose groups: Anlotinib 8mg per day plus paclitaxel and carboplatin. middle-dose groups: Anlotinib 10mg per day plus paclitaxel and carboplatin. high-dose groups: Anlotinib 12mg per day plus paclitaxel and carboplatin to determine the appropriate dose of anlotinib in combination with paclitaxel and carboplatin | Drug | Squamous cell lung cancer |
| Anlotinib combined with pemetrexed and carboplatin, phase IIAlso: APCIIAnlotinib: established dose QD PO d1-14, pemetrexed,carboplatin, 21 days per cycle after 4-6 cycles, Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent | Drug | Non-squamous cell lung cancer |
| Anlotinib combined with paclitaxel and carboplatin, phase IIAlso: ATCIIAnlotinib :established dose QD PO d1-14, paclitaxel,carboplatin, 21 days per cycle after 4-6 cycles, Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent | Drug | Squamous cell lung cancer |
Primary outcome
Progress free survival (PFS)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause,whichever came first.up to 12 months
progression free survival
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: each 21 days up to the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Overall Survival (OS)
Time frame: From enrollment until death (up to 36 months)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (Safety)
Time frame: Time Frame: each 21 days up to the toxicity or PD (up to 36 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Results publication: PubMed 29438373Han B, Li K, Zhao Y, Li B, Cheng Y, Zhou J, Lu Y, Shi Y, Wang Z, Jiang L, Luo Y, Zhang Y, Huang C, Li Q, Wu G. Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302). Br J Cancer. 2018 Mar 6;118(5):654-661. doi: 10.1038/bjc.2017.478. Epub 2018 Feb 13.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anlotinib combined with pemetrexed and carboplatin, phase I, Anlotinib combined with paclitaxel and carboplatin, phase I and Anlotinib combined with pemetrexed and carboplatin, phase II in people with NSCLC and Adenocarcinoma, run by Chinese Academy of Medical Sciences.
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 7 inclusion and 11 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 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yuankai Shi, MD (+86 13701251865, syuankaipumc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress free survival (PFS) (time frame: From date of enrollment until the date of first documented progression or date of death from any cause,whichever came first.up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03636685, which also lists 1 linked publication.
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 17 Aug 2018.