Upfront stereotactic body radiotherapy with chemotherapy for stage III non-small cell lung cancer

The APRIL Trial: A Phase II Trial Evaluating Upfront Stereotactic Body Radiotherapy in Stage III Advanced Non-small Cell Lung Cancer

This trial will test whether giving high-precision stereotactic body radiotherapy (SBRT) together with chemotherapy upfront can improve loco-regional tumor control for adults with stage III non-small cell lung cancer whose tumors and involved lymph nodes meet the study's size limits.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: All India Institute of Medical Sciences (other)
• Drugs / interventions: chemotherapy, cetuximab, radiation
• Locations: 1 site (Jhajjar, Haryana)
• Trial ID: NCT07565987 on ClinicalTrials.gov

What this trial studies

The trial combines high-dose, conformal SBRT delivered in a small number of fractions with systemic chemotherapy given up front for selected patients with stage III NSCLC. Eligibility is limited to patients with a primary tumor ≤6 cm and limited nodal burden (≤3 nodal stations, largest node ≤4 cm), ECOG 0–1, and no distant metastases. The protocol aims to test feasibility, measure loco-regional control rates, and closely monitor toxicity and survival with preplanned long-term follow-up. The single-center study is run at AIIMS Jhajjar and requires participants to attend for treatment visits and follow-up assessments.

Who should consider this trial

Good fit: Adults 18–74 years with histologically confirmed stage III non-small cell lung cancer, ECOG 0–1, tumor ≤6 cm, limited nodal disease (≤3 stations and nodes ≤4 cm), no metastases, and no prior thoracic radiotherapy are the intended participants.

Not a fit: Patients with large tumors (>6 cm), extensive nodal involvement (>3 stations or nodes >4 cm), invasion of central structures, prior thoracic radiation, poor performance status, metastatic disease, or contraindications such as pregnancy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could improve local tumor control and possibly survival while delivering higher biologic radiation doses in fewer treatments with acceptable toxicity.

How similar studies have performed: High-BED SBRT has produced excellent local control in early-stage NSCLC, but using upfront SBRT combined with chemotherapy in stage III disease is relatively novel and has limited prospective evidence to date.

Eligibility criteria

Inclusion Criteria:

1. Aged 18 or above and less than 75 years.
2. Histologically proven non-small cell lung cancer.
3. Stage T1-4, N1-3, M0 with maximum tumor size less than 6 cms and ≤ 3 stations of largest lymph node size less than 4 cms.
4. ECOG status 0-1.
5. Available to attend long term follow- up.
6. Written informed consent for treatment.

Exclusion Criteria:

1. Metastatic disease.
2. Tumor size \> 6cm.
3. Involved Lymph node size greater than 4 cms \& more than 3 station of lymph nodes involved.
4. Patients with superior vena cava obstruction.
5. Tumor invading/encasing the proximal bronchial tree/, esophagus, pericardium.
6. Previous radiotherapy to thorax.
7. Small cell histology.
8. Age\< 18 or \> 75 years.
9. Patients on anticoagulant therapy \& ultra-central cavitary tumors.
10. Poor performance status ECOG 2-3.
11. Immunocompromised states.
12. Viral Markers negative.
13. Pregnant women

Where this trial is running

Jhajjar, Haryana

• Nci, Aiims-Jhajjar — Jhajjar, Haryana, India (RECRUITING)

Study contacts

• Study coordinator: Aman Sharma, MD

Conditions: Non Small Cell Lung Cancer