Phase II clinical study of autologous RAK cells combined with icotinib in the treatment of EGFR-mutated advanced non-small cell lung cancer

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200055244

Enrollment

Unknown

Registered

2022-01-04

Start date

2016-06-01

Completion date

Unknown

Last updated

2023-01-23

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

Experimental group:Autologous RAK cells combined with icotinib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Written informed consent form (with written approval from the independent ethics committee of the research institution and signed prior to conducting the research; 2. Aged >= 18 years; 3. Locally advanced (stage IIIb) or metastatic (stage IV) lung adenocarcinoma confirmed by histology or cytology that cannot be treated by surgery; 4. EGFR sensitive mutation (exon 19 deletion mutation or exon 21 L858R) detected by histology or peripheral blood; 5. Have not received other EGFR-related targeted therapy; 6. Those with measurable lesions according to RECIST1.1 standard; 7. Eastern Cooperative Oncology Group Physical Status Score (ECOG PS) 0-2 points; 8. Life expectancy >= 12 weeks; 9. Blood routine examination: absolute neutrophil value (ANC) >= 1.0 x 10^9/L, platelet count >= 75 x 10^9/L, and hemoglobin >=8 g/dL; 10. Blood biochemical tests: total bilirubin = 50 mL/min; 11. Women of childbearing age must undergo a serum or urine pregnancy test 7 days before enrollment. Both male and female patients were required to agree and pledge to use contraception during the trial.

Exclusion criteria

Exclusion criteria: 1. Received chest radiotherapy within 28 days before enrollment; 2. Patients with previously diagnosed autoimmune diseases; 3. Those who have undergone major surgical operations (including open thoracic biopsy) within 28 days before enrollment, and suffered major trauma; 4. Pregnant and lactating patients; 5. Simultaneous application of other anti-tumor drugs; 6. Received any other experimental drug treatment or participated in another clinical trial within 28 days before enrollment; 7. The patient has mental illness or no self-judgment ability.

Design outcomes

Primary

Measure	Time frame
progression-free survival;	—

Secondary

Measure	Time frame
diease control rate;objective response rate;	—

Countries

China

Contacts

Public ContactMa Jie

Beijing Hospital

majie1965@163.com+86 10 85133661

Outcome results

None listed

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