Current partner codePEPTIDESDE
NCT02787447·Phase 2·INTERVENTIONAL

Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy

Status

Unknown

Phase

Phase 2

Enrollment

46

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The investigators postulated that the exploitation of the pro-immunogenic effects of radiotherapy with thymosin might result in abscopal responses among patients with metastatic cancer. The research is designed to evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy combined with thymosin alpha 1. An exploratory biomarker analysis in blood and tumor samples is also planned.

Interventions

Treatment arms and agents.

DRUG

TKI

Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid

RADIATION

Thoracic Hypofractionated Radiotherapy

40-45 Gy/5-15f

DRUG

Thymosin Alpha 1

Initiating thymosin alpha 1 therapy(1.6mg, qd, d1-d14;1.6mg, biw, d15-d90) at the second week of radiotherapy.

Timeline

From registration to results.

  1. First posted

    Jun 1, 2016

  2. Study start

    May 2016

  3. Primary completion

    Dec 2017

  4. Study completion

    May 2020

  5. Results posted

    Not reported

  6. Registry updated

    Nov 25, 2016

Outcomes

What the study measures.

Primary outcomes

The proportion of patients with an abscopal response assessed at 1-6 months after the radiation therapy

Time frame · 1-6 months

To assess the proportion of patients with an abscopal response (defined as at least a 30% decrease in the longest diameter of the best responding abscopal lesion) at 1-6 months after the radiation therapy

Secondary outcomes

To assess the short-term quality of life (QOL)

Time frame · 4 months

FACT-E score at the 4 months after docetaxel consolidation therapy

Rate of CTCAE grade 2 or higher radiation pneumonitis

Time frame · 1 years

The investigators will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy

Overall Survival

Time frame · 2 years

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Newly diagnosed metastatic lung adenocarcinoma harboring sensitizing EGFR mutations (L858R, exon 19 deletion), and showed stable disease after 3 months TKI, evaluated twice by PET/CT scan, brain MRI, and abdomen ultrasound (≥3 measurable lesions, and these lesions haven't received local therapy) * Age 18 years or older * ECOG Performance Status 0-2 * Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal * For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment * Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter * Patients and their family signed the informed consents Exclusion Criteria: * Received chemotherapy before TKI therapy * Brain parenchyma or leptomeningeal disease * Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment * Any medical co-morbidities that would preclude radiation therapy.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Thymosin Alpha-1.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.