Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001210369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
28/08/2026
Date registered
Help: Date registered
30/09/2026
Date last updated
Help: Date last updated
30/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
30/09/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Bronchoscopic Tumour Ablation for Immune Priming to Enhance Neoadjuvant Chemotherapy and Immunotherapy in Resectable Non-Small Cell Lung Cancer (IMPRINT Study): A Single-Arm Open Label Feasibility Study
Scientific title
Bronchoscopic tumour ablation for immune priming to enhance neoadjuvant chemotherapy and immunotherapy in patients with resectable non-small cell lung cancer (IMPRINT study): A single arm open label feasibility study.
Additional trial identifiers [1] 318283 0
Nil
Universal Trial Number (UTN)
Trial acronym
IMPRINT
Related trial records

Health condition
Health condition(s) studied:
non-small cell lung cancer 343404 0
Condition category
Condition code
Cancer 339485 339485 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This study will determine if bronchoscopic thermal ablation prior to neoadjuvant chemo-immunotherapy can be performed without compromising the delivery of standard neoadjuvant care.

Patients with resectable confirmed NSCLC who are elgible for standard of care neoadjuvant chemo-immunotherapy prior to resection will be recruited.

A single dose of bronchoscopic radiofrequency ablation (RFA) will be delivered to target lung cancer. RFA involves the delivery of a measured dose of radiofrequency energy to the area of the cancerous lesion. This will be delivered via a RFA catheter that is introduced to the lung cancer via a bronchoscope. The RFA will be delivered by an interventional pulmonologist (respiratory physician) in a bronchoscopy suite within a hospital. The procedure will be performed under general aneasthesia. Dose(s) of up to 70 watts of energy is delivered to targeted lung lesions (according to a CT guided therapy plan) during a single bronchoscopic procedure. This procedure will generally take less than 60 minutes to perform. Patients will have a CT scan of the chest one week post ablation to assess the ablative area.

Following RFA patients will continue standard of care treatment, this will include neoadjuvant chemotherapy and immunotherapy (three doses) followed by surgical resection. Chemotherapy and immunotherapy will be delivered as per standard clinical care for the patient. This will be in accordance with the regimen established in the phase III CheckMate 816 trial (NCT02998528) and approved by the eviQ committee for clinical use in Australia, Patients will receive three cycles of platinum-doublet chemotherapy plus nivolumab (360 mg) intravenously every 3 weeks. Surgical resection (lobectomy) will be performed at the completion of neoadjuvant chemo-immunotherapy.

The first dose of chemo-immunotherapy will be delivered within 1 week of RFA procedure. Patients will be monitored during the period from ablation to resection (a period of 3 months) to monitor safety profile of ablation. Surgical resection specimens will be analysed to assess degree of tumour cell death.

Intervention code [1] 335194 0
Treatment: Devices
Description of the comparator or control
This is an early stage feasibility study to assess the safety and feasibilty of adding bronchoscopic RFA prior to standrad clinical care neoadjuvant chemo-immunotherapy and resection. All participants will recieve same ablative therapy followed by neoadjuvant chemo-immunotherapy and surgery.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346694 0
Feasibility of additional bronchoscopic radiofrequency ablation to neo-adjuvant standard of care.
Timepoint [1] 346694 0
Cumulative data will be assessed at the conclusion of the recruitment period
Secondary outcome [1] 467034 0
Recruitment viability.
Timepoint [1] 467034 0
Study will review viability at 3 months, 6 months, 12 months, 15 months, 18 months, 21 months, 24 months post study commencement.
Secondary outcome [2] 467035 0
Surgical and treatment Feasibility - proportion of patients successfully completing standard of care treatment which includes neoadjuvant chemo-immunotherapy followed by surgical resection.
Timepoint [2] 467035 0
THis will performed at conclusion of study (24 months post-study commencement)
Secondary outcome [3] 467036 0
Efficacy - Pathologic response - rates of pathologic complete response (pCR)
Timepoint [3] 467036 0
10-12 weeks post ablation
Secondary outcome [4] 467037 0
Safety
Timepoint [4] 467037 0
Reviewed continuously from baseline (time of ablation) until day 1 post resection (10-12 weeks later)
Secondary outcome [5] 467783 0
Efficacy - Radiographic response
Timepoint [5] 467783 0
8-10 weeks post ablation
Secondary outcome [6] 467784 0
Surgical and treatment Feasibility - ablation related surgical complications
Timepoint [6] 467784 0
At time of surgery
Secondary outcome [7] 468494 0
Efficacy - Pathologic response - rates of major pathologic response (MPR)
Timepoint [7] 468494 0
10-12 weeks post ablation

Eligibility
Key inclusion criteria
1) Age over 18 years.
2) Confirmed Stage IIA-IIIA NSCLC and recommended for neoadjuvant Chemo-IO followed. by resection at Lung Multi-disciplinary tumour board meeting.
3) Recommended surgical resection is lobectomy.
4) Pre-ablated parenchymal tumour/lesion size is greater than or equal to 20mm.
5) Signs informed consent form.
6) Planned ablation zone margin is greater than or equal to 10mm away from the pleural surface, mediastinum, diaphragm and/or spine.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
a) Age under 18 years
b) Mixed type SCLC
c) EGFR/ALK/ROS1 mutation positive
d) Tumour <20mm in size(T1a, T1b)
e) Any contraindication to bronchoscopy
f) Any contraindication to surgery
g) Recommended resection is pneumonectomy
h) Known coagulopathy/platelet dysfunction or platelet count <100 x109/L
i) Suspected pulmonary hypertension
j) Moderate-to-severe pulmonary fibrosis
k) Severe emphysema/COPD (GOLD III/IV)
l) Contraindication to general anaesthesia

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is an open label, single arm, feasibility study with a stop/go approach using a Simon’s two stage framework to assess the primary endpoint. The primary endpoint to be assessed is treatment integrity which has been defined as the proportion of patients who undergo ablation and commence neoadjuvant chemo-immunotherapy within 2 weeks of MDM treatment decision. A sample size of 9 has been calculated for the first stage with a further 20 to be recruited in the second stage if the feasibility endpoint is met as per the Simon’s two stage framework. See power calculation below for further detail.

Simon's two-stage design will be used. The null hypothesis that the true response rate (that ablation can be safely administered with subsequent chemo-immunotherapy within 2 weeks of MDM decision) is 0.8 will be tested against a one-sided alternative. In the first stage, 9 patients will be accrued. If there are 7 or fewer responses in these 9 patients, the study will be stopped. Otherwise, 20 additional patients will be accrued for a total of 29. The null hypothesis will be rejected if 27 or more responses are observed in 29 patients. This design yields a type I error rate of 0.05 and power of 0.8 when the true response rate is 0.95.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2026
Actual
Date of last participant enrolment
Anticipated
30/09/2028
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
29
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 30088 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 30089 0
The Northern Hospital - Epping
Recruitment hospital [3] 30090 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 30091 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [5] 30092 0
Western Hospital - Footscray - Footscray
Recruitment postcode(s) [1] 46483 0
3050 - Parkville
Recruitment postcode(s) [2] 46484 0
3076 - Epping
Recruitment postcode(s) [3] 46485 0
3084 - Heidelberg
Recruitment postcode(s) [4] 46486 0
3168 - Clayton
Recruitment postcode(s) [5] 46487 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 322838 0
Hospital
Name [1] 322838 0
The Royal Melbourne Hospital - in kind funding
Country [1] 322838 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 325771 0
None
Name [1] 325771 0
Address [1] 325771 0
Country [1] 325771 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321276 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 321276 0
Ethics committee country [1] 321276 0
Australia
Date submitted for ethics approval [1] 321276 0
25/03/2026
Approval date [1] 321276 0
23/07/2026
Ethics approval number [1] 321276 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 153218 0
Dr Kanishka Rangamuwa
Address 153218 0
Department of Respiratory Medicine, THe Royal Melbourne Hospital, 300 Grattan St, Parkville, Victoria 3050
Country 153218 0
Australia
Phone 153218 0
+61 3 9342 7708
Fax 153218 0
Email 153218 0
[email protected]
Contact person for public queries
Name 153219 0
Kanishka Rangamuwa
Address 153219 0
Department of Respiratory Medicine, THe Royal Melbourne Hospital, 300 Grattan St, Parkville, Victoria 3050
Country 153219 0
Australia
Phone 153219 0
+61 3 9342 7000
Fax 153219 0
Email 153219 0
[email protected]
Contact person for scientific queries
Name 153220 0
Kanishka Rangamuwa
Address 153220 0
Department of Respiratory Medicine, THe Royal Melbourne Hospital, 300 Grattan St, Parkville, Victoria 3050
Country 153220 0
Australia
Phone 153220 0
+61 3 9342 7708
Fax 153220 0
Email 153220 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.