Efficacy and safety of Formeta plus Carboplatin in lung cancer

Efficacy and safety of Formeta plus Carboplatin in advanced non-squamous, non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016091322610N2

Enrollment

Registered

2016-10-24

Start date

2016-09-05

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Malignant neoplasm of bronchus and lung. Malignant neoplasm of bronchus and lung

Interventions

Intervention groups: Eligible patients will be assigned to receive Formeta (by Cobel Zist Darou) 500 mg/m2 and Carboplatin area under curve (AUC) 5 every 3 weeks i.v. One to three weeks prior to start

Treatment - Drugs

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Histologically confirmed non- squamous, non small cell lung cancer;age = 18 years old; performance status (PS) 0-2(at Eastern Cooperative Oncology Group); stages IIIB and IV (by AJCC, 7th edition);no prior chemotherapy or biologic therapy; no history of radiotherapy in 14 days ago; no mutation of Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) translocation genes. Exclusion criteria: Histologically small cell lung cancer or squamous cell lung cancer;age< 18 years old; performance status (PS) 3 or 4 (at Eastern Cooperative Oncology Group); stages I , II or IIIA (by AJCC, 7th edition);prior chemotherapy or biologic therapy; history of radiotherapy in 14 days ago; mutation of Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) translocation genes.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Progression free survival. Timepoint: From date of pathologic diagnosis to disease relapse(progression). Method of measurement: Time (months).;Overall survival. Timepoint: From date of pathologic diagnosis to death. Method of measurement: Time (months).	—

Secondary

Measure	Time frame
Safety. Timepoint: Before each chemothrapy cycle starting. Method of measurement: Visit, questionare and labs tests( according to CTCAE, version 3.0).;Response rate. Timepoint: After 3rd chemothepy cycle. Method of measurement: Response Evaluation Criteria in Solid Tumors (RECIST) criteria.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAdnan Khosravi

Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung D

adkhosravi@yahoo.com; adkhosravi@sbmu.ac.ir+98 21 2610 9946

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026