ATOM_local Ablative Therapy

NCT01941654 | Completed Phase 2

• 1 other identifier: LUN060
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy of preemptive local ablative therapy in NSCLC patients with activating EGFR mutation who have oligometastatic residual metabolic-active disease after first-line EGFR TKI, as measured by PFS rate at 1 year from the trial enrollment.

Conditions

NSCLC; Activating EGFR Mutation

Outcome Measures

Primary Outcomes (1)

• PFS rate at 1 year

  2 years

Secondary Outcomes (4)

• Overall survival

  2 years

• Progression-free survival

  2 years

• radiologic change on PET-CT scan 3 months after SABR

  3 months

• Number of Participants with Adverse Events as a Measure of safety

  2 years

Study Arms (1)

preemptive local ablative therapy

EXPERIMENTAL

Radiation: preemptive local ablative therapy; Drug: Oral TKI

Interventions

preemptive local ablative therapy RADIATION

preemptive local ablative therapy

Oral TKI DRUG

preemptive local ablative therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed UICC 7th edition Stage IIIB (not amenable for curative intent local radiotherapy)/IV (metastatic or recurrent) non-small cell carcinoma of lung
• Documented activating EGFR mutation (exon 19 deletion or exon 21 L858R only) in tumor tissues
• Treated with first-line EGFR TKI for 3 months and achieved good radiological partial response that was documented with a CT scan
• Not more than 4 residual metabolic active (SUVmax \> 2.5) metastatic sites left on the screening PET-CT scan. (one bone metastatic site is regarded as a single site, mediastinal/ hilar lymph nodes in close proximity and possible to be treated in an acceptable volume is regarded as one lesion)
• The shortest diameter of the lesion must be ≥ 1cm and is amenable to local ablative therapy
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
• Age ≥ 18 years
• Pleural or pericardial effusion at diagnosis is allowed only if it has resolved on CT scan after 3-month EGFR TKI treatment
• Brain metastasis at diagnosis is allowed if it has been treated either surgically or with radiotherapy and there is no radiological progression on follow-up CT scan. The patient is neurologically stable for at least 1 week after cessation of steroid treatment
• Adequate organ function as defined by the following criteria:
• Serum alanine transaminase ≤ 3 x upper limit of normal (ULN) or ≤ 5 x ULN if liver function abnormalities are due to liver metastases
• Total bilirubin ≤ 1.5 x ULN
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Platelets count ≥ 100 x 109/L
• Creatinine clearance \> 45ml/min

You may not qualify if:

• Prior chemotherapy is not allowed except adjuvant chemotherapy for completely resected early staged non-small cell lung cancer and it has been at least 12 months before the start of EGFR TKI treatment
• Prior radiotherapy is not allowed except brain irradiation
• Leptomeningeal carcinomatosis
• Lymphangitis carcinomatosis of lung
• Prior or concomitant malignancy at other sites is not allowed except treated non-metastatic non-melanoma skin cancer, ductal carcinoma-in-situ of breast and carcinoma-in-situ of cervix with curative intent
• Uncontrolled active infection or medical condition (e.g. uncontrolled hypertension, unstable angina, congestive heart failure \[≥ NYHA Class II\], uncontrolled arrhythmia, myocardial infarction or cerebrovascular accident within the past 6 month)
• Pre-existing interstitial lung disease
• Woman of child-bearing potential or male patient is unwilling to use adequate birth control method prior to the study entry, for the duration of study participation and for at least 2 months after the EGFR TKI treatment has ended.
• Pregnant and Lactating female patient
• Non-compliance to the study procedure

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Pamela Youde Nethersole Eastern Hospital: collaborator

Study Sites (1)

Department of Clinical Oncology

Hong Kong, Hong Kong

Location

Study Officials

• Kwok Chi LAM, FRCP

  Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Comprehensive Cancer Trials Unit

Model Details: RT + Oral TKI

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 13, 2013
• Study Start: September 18, 2013
• Primary Completion: December 31, 2017
• Study Completion: May 28, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Locations

HK (1)