Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Progressed After Icotinib Treatment

A Phase II Randomised, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Who Have Progressed After Icotinib Treatment in NSCLC

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01707329

Enrollment

180

Registered

2012-10-16

Start date

2012-09-30

Completion date

2016-12-31

Last updated

2015-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Brief summary

This phase II randomised, double blind, placebo controlled, multicentre trial is designed to assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy alone in patients who have progressed after benefiting from previous second or third-line icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell lung cancer.

Interventions

DRUGChemotherapy

Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.

DRUGIcotinib+chemotherapy

Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology) * No previous targeted treatment such as gefitinib, erlotinib. * With a measurable disease(longest diameters \>=10mm with Spiral computed tomography (CT)and \>=20mm with conventional CT) according to RECIST Criteria * WHO performance status(PS)\<= 2 * N\>=1.5×109/L, Plt\>=1.0×109/L,Hb\>=10g/dL;AST&ALT should \<3ULN(without liver metastasis) or \<5ULN(with liver metastasis).TBIL\<=1.5ULN. * Signed and dated informed consent before the start of specific protocol procedures.

Exclusion criteria

* Allergic to icotinib * Patients with metastatic brain tumors with symptoms. * Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab. * Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

Design outcomes

Primary

Measure	Time frame	Description
Progression Free Survival	6 months	A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.

Secondary

Measure	Time frame	Description
Overall survival	12 months	Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.

Countries

China

Contacts

Primary ContactZhang Yi Ping, MD

zyp@medmail.com.cn0086-13750881678

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026