Study of Anlotinib Plus Chemotherapy as the First-line Treatment in Patients With Advanced NSCLC
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ClinicalTrials.gov Identifier: NCT03636685 |
Recruitment Status : Unknown
Verified August 2018 by Shi Yuankai, Chinese Academy of Medical Sciences.
Recruitment status was: Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
NSCLC Adenocarcinoma Squamous Cell Carcinoma | Drug: Anlotinib combined with pemetrexed and carboplatin, phase I Drug: Anlotinib combined with paclitaxel and carboplatin, phase I Drug: Anlotinib combined with pemetrexed and carboplatin, phase II Drug: Anlotinib combined with paclitaxel and carboplatin, phase II | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Estimated Study Start Date : | August 15, 2018 |
Estimated Primary Completion Date : | August 14, 2019 |
Estimated Study Completion Date : | August 14, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Non-squamous cell lung cancer
Anlotinib combined with pemetrexed and carboplatin, phase I Anlotinib combined with pemetrexed and carboplatin, phase II |
Drug: Anlotinib combined with pemetrexed and carboplatin, phase 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 Other Name: APC I Drug: Anlotinib combined with pemetrexed and carboplatin, phase II 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
Other Name: APCII |
Experimental: Squamous cell lung cancer
Anlotinib combined with paclitaxel and carboplatin, phase I Anlotinib combined with paclitaxel and carboplatin, phase II |
Drug: Anlotinib combined with paclitaxel and carboplatin, phase 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 Other Name: ATC I Drug: Anlotinib combined with paclitaxel and carboplatin, phase II 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 Other Name: ATCII |
- 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
- Objective Response Rate (ORR) [ Time Frame: each 21 days up to the toxicity or PD (up to 24 months) ]Objective Response Rate
- Disease Control Rate (DCR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]Disease Control Rate
- Overall Survival (OS) [ Time Frame: From enrollment until death (up to 36 months) ]Overall survival
- 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) ]Number of Participants with Adverse Events as a Measure of Safety and Tolerability

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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

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): NCT03636685
Contact: Yuankai Shi, MD | +86 13701251865 | syuankaipumc@126.com | |
Contact: Zhaoyuan Shi | +8615801570739 | szy957@aliyun.com |
Responsible Party: | Shi Yuankai, Vice President of Cancer Hospital Chinese Academy of Medical Sciences, Chinese Academy of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT03636685 |
Other Study ID Numbers: |
NCC201807006 |
First Posted: | August 17, 2018 Key Record Dates |
Last Update Posted: | August 17, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Anlotinib NSCLC platinum-based chemotherapy |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Paclitaxel Albumin-Bound Paclitaxel Carboplatin Pemetrexed |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |