Lattice radiotherapy with immunotherapy and chemotherapy for locally advanced non-small cell lung cancer

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with stage III lung cancer that cannot be removed by surgery. Their tumor responded only partly to earlier chemo-immunotherapy.

Age

18 years or older

Sex

All sexes can join

Disease stage

Unresectable stage III locally advanced non-small cell lung cancer, confirmed by tissue examination

Earlier treatment

At least 2 cycles of standard neoadjuvant chemoimmunotherapy, with a suboptimal tumor response shown on scans. No earlier radiotherapy to the chest.

Main reasons for not taking part

• Earlier radiotherapy to the chest
• Active uncontrolled autoimmune disease or persistent severe immune-related side effects
• Untreated brain metastases that cause symptoms
• Severe irreversible heart, lung, liver or kidney problems
• Pregnant or breastfeeding women

The registry criteria, word for word

What the trial wants to find out

Lattice radiation therapy (LRT) is a spatially fractionated thoracic radiotherapy technique that creates alternating high- and low-dose regions within primary lung tumors and metastatic lymph nodes to strengthen local tumor suppression and reduce radiation injury to normal thoracic organs. This study aims to evaluate the efficacy and safety of combining LRT with consolidation chemoimmunotherapy in unresectable stage III LA-NSCLC patients who show suboptimal tumor response to prior neoadjuvant chemoimmunotherapy, through a single-arm Phase II clinical trial. Patients will receive thoracic LRT delivered by a medical linear accelerator. High-dose spherical sub-targets will be contoured within the gross tumor volume of primary lung lesions and regional nodal metastases under standardized dose constraints to spare the lung, heart and esophagus. All enrolled subjects will receive sequential consolidation chemoimmunotherapy administered within one week after finishing LRT. Tumor response, treatment-related adverse events, local tumor control and long-term survival outcomes will be prospectively tracked throughout treatment and long-term follow-up.

The group in the trial

• experimental groupTreatment being tested

  Eligible patients with unresectable stage III LA-NSCLC who achieved suboptimal tumor response after prior neoadjuvant chemoimmunotherapy in this Phase II trial will receive thoracic lattice radiation therapy using a medical linear accelerator. Within the gross tumor volume (GTV) of primary lung lesions and metastatic regional lymph nodes, spherical high-dose LRT sub-targets will be delineated with fixed diameter and inter-target spacing standards. The LRT sub-targets must be contoured fully within the GTV, spare vital intrathoracic vessels, maintain a minimum safety margin from the outer GTV border, and account for a regulated volume percentage of the whole GTV. For thoracic tumor lesions, the D95 coverage of total GTV and individual LRT high-dose targets will follow defined per-fraction dose limits, while all efforts will be made to lower single-fraction radiation burden to lung, heart and esophagus organs at risk. After finishing the full course of lattice radiotherapy, standardized

  Treatment: lattice radiation therapy