Combining radiotherapy and immunotherapy in early stage non-small-cell lung cancer patients: exploring safety and immunological proof of principle.

Phase 1

• Conditions: Early stage (T1N0 and T2N0) non-small cell lung cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003819-36-NL
• Lead Sponsor: VU Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-25
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

histologically histologically or cytologically confirmed diagnosis of early stage (T1bN0 and T2aN0) peripherally located NSCLC, eligible for surgical resection. Highly suspected NSCLC is defined as an a priori change of >85% that the lesion is malignant, according to the publication of Herder et al. (59)
Be willing and able to provide written informed consent/assent for the trial.
Be 18 years of age or older on day of signing imformed consent.
Have measurable disease based on RECIST 1.1.
Must provide tissue from a core or excisional biopsy of the primary tumor lesion.
Have a performance status of 0-1 on the ECOG Performance Scale.
Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 10 days of treatment initiation.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subjects of childbearing potential should be willing to use two methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not ben free form menses for >1 year.
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Is currently participating in or has participated in a study of an investigational agent or using investigational device within 4 weeks of the first dose of treatment.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days proor to the first dose of trial treatment.
Has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered (i.e. grade 1 or lower, or at baseling) from adverse events due to agents administered more than 4 weeks earlier.
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e. grade 1 or lower at baseline) from adverse events due to a previously administered agent.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cel carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented histroy of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.
Has a history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.
Has an active infection requiring systemic therapy.
Has a histroy or current evidence of any condition ,therapy or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the bst interest of the subject to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abude disorders that would interfere with cooperation with the requirements of the trial.
Is pregnant or breastfeedig, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
Has known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C (e.g. HCV RNA [qualitative] is detected).
Has received a live vaccine within 30 days prior to the first dose of trial treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified