Phase II trial of gemcitabine monotherapy in the third or further line for pretreated patients with advanced non-small cell lung cancer

Phase II trial of gemcitabine monotherapy in the third or further line for pretreated patients with advanced non-small cell lung cancer - OPH-RM-LC-1502

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017791

Enrollment

Registered

2015-06-04

Start date

2015-06-04

Completion date

Unknown

Last updated

2026-06-29

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

Interventions

gemcitabine monotherapy (1000mg/m2, Day1,8,15, every four week)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed non-small cell lung cancer 2) Stage III / IV or recurrence after surgery, without any indications for radiotherapy or surgery 3) Evaluable disease 4) Progressive disease or recurrence after one or more platinum-based regimens, two or more regimens containing cytotoxic drugs, docetaxel- or pemetrexed-containing regimen for non-squamaous cell carcinoma histology, and docetaxel-containing regimen for squamous cell carcinoma histology. Adjuvant platinum-based chemotherapy was considered as one regimen. 5) Pre-treated with EGFR-TKI in patients with active EGFR mutation. 6) Pre-treated with ALK inhibitor in ALK-positive patient 7) Interval; two week after thoracic radiotherapy 8) Age 20 year-old or over 20 year-old 9) ECOG Performance status 0-2 10) Adequate organ function, evaluated within 14 days before enrollment 11) Expected 12 weeks survival 12) Written informed consent

Exclusion criteria

Exclusion criteria: 1) A history of gemcitabine treatment 2) Current or previous history of pulmonary fibrosis, interstitial pneumonitis or drug-induced pneumonia, revealed by chest X-ray film 3) Concurrent thoracic radiotherapy 4) A history of severe hypersensitivity against gemcitabine 5) Another active advanced malignancy that requires any concurrent treatment with treatment for lung cancer 6) Pleural effusion, ascites or peri-cardiac effusion requiring dranage. 7) Problematic complications 8) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 9) Decision of ineligibility by a physician

Design outcomes

Primary

Measure	Time frame
Progression-free survival(PFS)	—

Secondary

Measure	Time frame
Response rate (RR), Overall survival (OS), 1yr-survival rate, adverse effects, QOL assessment	—

Countries

Japan

Contacts

Public ContactSeigo Minami

Osaka Police Hospital Dept. of Respiratory Medicine

seigominami@oph.gr.jp06-6771-6051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026