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Study of Anlotinib Plus Chemotherapy as the First-line Treatment in Patients With Advanced NSCLC

Primary Purpose

NSCLC, Adenocarcinoma, Squamous Cell Carcinoma

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for NSCLC focused on measuring Anlotinib, NSCLC, platinum-based chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Non-squamous cell lung cancer

Squamous cell lung cancer

Arm Description

Anlotinib combined with pemetrexed and carboplatin, phase I Anlotinib combined with pemetrexed and carboplatin, phase II

Anlotinib combined with paclitaxel and carboplatin, phase I Anlotinib combined with paclitaxel and carboplatin, phase II

Outcomes

Primary Outcome Measures

Progress free survival (PFS)

progression free survival

Secondary Outcome Measures

Objective Response Rate (ORR)

Objective Response Rate

Disease Control Rate (DCR)

Disease Control Rate

Overall Survival (OS)

Overall survival

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

Full Information

NCT ID

NCT03636685

First Posted

August 13, 2018

Last Updated

August 16, 2018

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03636685

Brief Title

Study of Anlotinib Plus Chemotherapy as the First-line Treatment in Patients With Advanced NSCLC

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 15, 2018 (Anticipated)

Primary Completion Date

August 14, 2019 (Anticipated)

Study Completion Date

August 14, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NSCLC, Adenocarcinoma, Squamous Cell Carcinoma

Keywords

Anlotinib, NSCLC, platinum-based chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Non-squamous cell lung cancer

Arm Type

Experimental

Arm Description

Anlotinib combined with pemetrexed and carboplatin, phase I Anlotinib combined with pemetrexed and carboplatin, phase II

Arm Title

Squamous cell lung cancer

Arm Type

Experimental

Arm Description

Anlotinib combined with paclitaxel and carboplatin, phase I Anlotinib combined with paclitaxel and carboplatin, phase II

Intervention Type

Drug

Intervention Name(s)

Anlotinib combined with pemetrexed and carboplatin, phase I

Other Intervention Name(s)

APC I

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Anlotinib combined with paclitaxel and carboplatin, phase I

Other Intervention Name(s)

ATC I

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Anlotinib combined with pemetrexed and carboplatin, phase II

Other Intervention Name(s)

APCII

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Anlotinib combined with paclitaxel and carboplatin, phase II

Other Intervention Name(s)

ATCII

Intervention Description

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

Primary Outcome Measure Information:

Title

Progress free survival (PFS)

Description

progression free survival

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

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Objective Response Rate

Time Frame

each 21 days up to the toxicity or PD (up to 24 months)

Title

Disease Control Rate (DCR)

Description

Disease Control Rate

Time Frame

each 42 days up to intolerance the toxicity or PD (up to 24 months)

Title

Overall Survival (OS)

Description

Overall survival

Time Frame

From enrollment until death (up to 36 months)

Title

Number of Participants with Adverse Events as a Measure of Safety and Tolerability (Safety)

Description

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time Frame

Time Frame: each 21 days up to the toxicity or PD (up to 36 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yuankai Shi, MD

Phone

+86 13701251865

syuankaipumc@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhaoyuan Shi

Phone

+8615801570739

szy957@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

29438373

Citation

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.

Results Reference

result

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Study of Anlotinib Plus Chemotherapy as the First-line Treatment in Patients With Advanced NSCLC

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