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OligoProgressive Metastatic DiseasePhase 2/3NCT07076693

Standard-of-care Systemic Therapy With or Without Local Therapy in Patients With Oligoprogressive Non-Small Cell Lung Cancer(NSCLC）

A Phase 2/3 study testing Radiotherapy or Surgery and Standard Medical Therapy in people with OligoProgressive Metastatic Disease and Non-Small Cell Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a randomized, controlled, phase II/III clinical study to evaluate the efficacy and safety of stand-of-care systemic therapy with local therapy versus stand-of-care systemic therapy in patients with oligoprogressive non-small cell lung cancer(NSCLC). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Radiotherapy or Surgery and Standard Medical Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
1 siteChina
Study dates
3 Jun 2025to 31 May 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign a written informed consent form and voluntarily participate in this study;
  • Age 18-75 years;
  • ECOG 0-1, or able to tolerate radiotherapy/surgery and subsequent systemic therapy;
  • For Epidermal Growth Factor Receptor (EGFR)-sensitive mutant non-squamous NSCLC patients, first-line treatment must be the third-generation TKIs or progression after first/second-generation TKI without harboring T790M mutation, with ≤3 progressive lesions and ≤3 metastatic organs (PET-CT + cranial MRI preferred, or comprehensive imaging assessment, pathological examination not mandatory);
  • For squamous cell lung cancer patients, progression after first-line immunotherapy/chemotherapy-immunotherapy with ≤3 progressing lesions and ≤3 metastatic organs (PET-CT + cranial MRI preferred, or comprehensive imaging assessment, pathological examination not mandatory);
  • Expected survival ≥6 months;
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  • No severe medical conditions;
  • Normal major organ functions, including:
  • Blood tests: WBC count ≥4.0×10⁹/L, neutrophil count ≥1.5×10⁹/L, platelet count ≥80×10⁹/L, hemoglobin ≥90 g/L;
  • Blood biochemistry: total bilirubin ≤1.5×ULN, ALT ≤2.5×ULN, AST ≤2.5×ULN, serum creatinine ≤1.5×ULN, or creatinine clearance ≥50 mL/min;
  • Coagulation function: INR ≤1.5×ULN; APTT ≤1.5×ULN; FEV1 > 0.75 L;
  • All oligoprogressive sites must be tolerable for radiotherapy or surgical treatment; for patients receiving radiotherapy, if prior radiotherapy was administered to the primary lesion, the re-irradiated site must be the metastatic lesions;
  • No other primary tumors before treatment;
  • PD-L1 expression status and driver gene sensitive mutations are both acceptable;
  • At least one evaluable target lesion, with metastases occurring within one month defined as synchronous metastases;
  • Patients may have more than 3 metastatic sites in total with only 1-3 progressive lesions and no more than 3 metastatic organs (RECIST criteria; mediastinal lymph nodes and primary lesions not counted in the oligopregressive lesions);
  • For patients with treated CNS disease, eligibility requires stable brain metastases on imaging and clinically, no evidence of cavitation or hemorrhage in brain lesions, asymptomatic status, and no need for steroids (must discontinue steroids at least 1 week before randomization); symptomatic brain metastases, multiple brain metastases, or other emergencies may receive palliative treatment before randomization (at least 1 week).

Who cannot join

  • Large cell neuroendocrine carcinoma, pulmonary carcinoid tumor, or mixed small cell and small cell lung cancer;
  • Patients with progressive lesions over 3 lesions;
  • Patients with meningeal metastasis, pleural metastasis, or severe pleural/ascitic effusion, or those who had severe pleural effusion during prior treatment but are now controlled;
  • Patients with any other current or previous malignancies, except for non-melanoma skin cancer or carcinoma in situ of the cervix;
  • Any other disease or condition that contraindicates radiotherapy/chemotherapy/immunotherapy (e.g., active infection, within 6 months after myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia, immunosuppressive therapy);
  • Other conditions deemed unsuitable for enrollment by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Chest Hospital, Shanghai, Recruiting

    Shanghai

Other trials in China

About this study

Official title: Standard-of-care Systemic Therapy With or Without Local Therapy in Patients With Oligoprogressive NSCLC: A Prospective, Randomized Controlled Phase II/III Clinical Trial

This is a randomized, controlled, phase II/III clinical study to evaluate the efficacy and safety of stand-of-care systemic therapy with local therapy versus stand-of-care systemic therapy in patients with oligoprogressive non-small cell lung cancer(NSCLC).

Read the detailed description

Subjects who meet all the inclusion criteria but do not meet any exclusion criteria are randomized into two groups at a ratio of 1:1: according to the stratification factors as below:

  • mutation status (known vs absent/unknown)
  • Number of oligoprogressive lesions (1-2 vs 3) Experimental group: For patients with oligoprogressive disease, local treatment (radiotherapy or surgery) is administered to all/partial oligoprogressive sites while providing standard systemic therapy for 4-6 cycles. Radiotherapy is administered with radiation dose 30-50Gy. The site and regimen of radiotherapy or surgery are primarily determined by the investigator. Maintenance therapy is determined by investigator assessment after evaluation.

Control group: Standard systemic therapy is administered for 4-6 cycles . Maintenance therapy is determined by investigator assessment after evaluation.

Adverse events (AEs) will be monitored throughout the study, and the severity will be graded to the guidelines listed in National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 or above. The safety will be followed up in the subjects who have received study treatment and discontinued the drug prematurely. All the subjects will be followed up for overall survival, until death, withdrawal of informed consent or end of study.

Being tested
Radiotherapy or Surgery, Standard Medical Therapy
Keywords
oligopregressive disease, local therapy, non-small cell lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiotherapy or SurgeryProcedure or surgery

    Metastatic lesions were treated with surgical resection or radiotherapy. Surgical duration was determined by investigator assessment and metastatic or primary lesions were resected with palliative intent. Radiation dose and fractionation are 30~50Gy. Radiation dose, fractionation regimen, and treatment sites for metastatic lesions were determined at the investigator's discretion based on clinical indications.

  • Standard Medical TherapyDrug

    Patients with squamous cell carcinoma received docetaxel administered in 3-week cycles, and patients with adenocarcinoma received pemetrexed, patinum and one of sintilimab or ivonescimab.

Study groups in NCT07076693
Study groupRoleWhat they receive
ExperimentalExperimentalFor patients with oligoprogressive disease, local treatment (radiotherapy or surgery) is administered to all/partial oligoprogressive sites while providing standard systemic therapy for 4-6 cycles. Radiotherapy is administered with radiation dose 30-50Gy. The site and regimen of radiotherapy or surgery are primarily determined by the investigator. Maintenance therapy or not is determined by investigator assessment after evaluation .
Receives: Procedure: Radiotherapy or Surgery; Drug: Standard Medical Therapy
Active ComparatorActive comparatorStandard systemic therapy is administered for 4-6 cycles. Maintenance therapy or not is determined by investigator assessment after evaluation.
Receives: Drug: Standard Medical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    The proportion of patients achieving complete remission (CR) or partial remission (PR)

    Measured: up to 7 weeks after standard subsequent-line therapy

  2. Progression-free survival (PFS)

    Time from randomization to disease progression or death

    Measured: up to 3 years

Secondary outcomes (5)

  1. Overall survival (OS)

    The time from random entry to death for any cause

    Measured: up to 3 years

  2. Local Control (LC)

    The time from the start of radiotherapy to any objectively recorded tumor progression at the irradiated site

    Measured: up to 3 years

  3. Adverse Events (AE)

    Number of participants with adverse events as assessed by CTCAE v5.0

    Measured: up to 3 years

  4. local treatment tolerability

    Number of participants with severe treatment--related adverse events as assessed by CTCAE v5.0 or who discontinue treatment

    Measured: up to 3 years

  5. treatment failure pattern

    The sites of disease progression post-treatment.

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start3 Jun 2025
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel
Masking
None (open label)
Enrolment
97 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07076693
Sponsor's protocol ID
IS25085
Status last verified
Jul 2025
First submitted
2 Jul 2025
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Radiotherapy or Surgery and Standard Medical Therapy in people with OligoProgressive Metastatic Disease and Non-Small Cell Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: up to 7 weeks after standard subsequent-line therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07076693.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.

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