Trial-specific Patient Decision Aid (tPDA) of the ImmunoSABR Phase 2

NCT04604470 | Unknown DMC

• 1 other identifier: UM2018IMMUNOSABR2RLPL_tPDA
• Study Type: observational
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a trial-specific (NCT03705403) decision aid (tPDA) for stage IV NSCLC patients that might want to participate. We want to investigate if a tPDA would be (significantly) helpful for these patients in making a decision. ImmunoSABR has a complex study design, we expect that the patients get a better overview of the trial via the tPDA because you can bring multiple tools together. (text, video, questions, pictures, timelines, etc.)

Conditions

NSCLC Stage IV; Lung Cancer; Non Small Cell Lung Cancer; Metastatic Cancer

Keywords

PDA; NSCLC; StageIV; Phase 2 trial; randomized controlled trial; international

Outcome Measures

Primary Outcomes (6)

• Patient's decisional needs to make a decision about participating a clinical trial

  Patients' decisional needs (development phase):semi-structured interviews with patients about the decision about their treatment, and what information the patients need to make.

  1 year

• Usability of the decision aid

  Quantitative research using a questionnaire based on the International Standard ISO-9242-11. This questionnaire measure to what extent the decision aid is easy to use. Answers will be clear for the patient; agree, neutral, disagree.

  1 year

• Decisional conflict (patients, evaluation phase)

  Decisional conflict will be assessed using the DCS (Decisional conflict scale): change in DCS between baseline group (usual care) and ImmunoSABR clinical trial. Answers will be clear for the patient; agree,neutral, disagree. Items are scored and summed. High total score will be in favour of the tPDA

  6months after randomization

• Control Preference Scale (patients; evaluation phase)

  Patient's preference to participate in medical decisions will be assessed using the 3-item Control Preference Scale (CPS):change in CPS between baseline group (usual care) and ImmunoSABR clinical trial . Questions and answers will be clear for the patient; agree, neutral, disagree. Items are scored and summed. High total score will be in favour of the tPDA

  6months after randomization

• Perception shared decision-making

  Patient's perception of the shared decision-making process will be assessed using the (shared decision making) SDM-Q9 instrument for patients: change in SDM between baseline group (usual care) and ImmunoSABR clinical trial. 9 questions with clear answers; totally disagree, strongly disagree, disagree, agree, strongly agree, totally agree.

  6months after randomization

• Perception shared decision-making

  Doctor's perception of the shared decision-making process will be assessed using the SDM-Q9 instrument for professionals: change in SDM between baseline group (usual care) and ImmunoSABR clinical trial. 9 questions with clear answers; totally disagree, strongly disagree, disagree, agree, strongly agree, totally agree.

  6months after randomization

Secondary Outcomes (2)

• Patients' satisfaction with decision aid

  6months after randomization

• Patients' intention to use and recommend tPDA to others

  6months after randomization

Study Arms (2)

Standard treatment

Chemotherapy Chemoradiotherapy Radiotherapy Immunotherapy Or a combination of above

Other: Decision tool

ImmunoSABR treatment

SABR combined immunotherapy Radiotherapy combined immunotherapy

Other: Decision tool

Interventions

Decision tool OTHER

no intervention.

ImmunoSABR treatment; Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage IV NSCLC patients

You may qualify if:

• Histological confirmed limited metastatic adult NSCLC patients, regardless of the PD-L1 status.
• Maximum of 10 metastatic lesions, maximum two brain lesion with a total cumulative diameter of 5cm is allowed.
• SOC baseline imaging e.g MRI and/or PET-CT and CT-brain or MRI brain and/or CT-scan with at least covering thorax-upper abdomen-brain, within 6 weeks prior to randomisation.
• If a patient has unclear lesions in the liver or brain an MRI would be advised following the ESMO guidelines.
• o In patients with 2 lung tumours, it can be unclear if the patient has 2 concurrent primary tumours or a primary lung tumour with 1 metastasis. In this case, the local multidisciplinary tumour board will decide whether the patient has an M1 disease or not.
• Previous treatment: Prior cancer treatments are allowed but must be discontinued for at least 4 weeks before randomisation. In case of maintenance chemotherapy, this therapy will only be started after the end of the L19-IL2 treatment or only in case of Anti-PD(L)1 treatment, during L19-IL2 therapy.
• Age of 18 years or older. WHO performance status 0-1; Adequate bone marrow function, evaluated in the local laboratory (Lab): Absolute Neutrophil Count (ANC) of ≥ 1.0 x 109 /L, platelet count ≥ 100 x 109/L, Haemoglobin (Hb) ≥ 6.0 mmol/L (or 9.67 g/dL) (it is allowed to give a blood transfusion if Hb is initially too low); Adequate hepatic function (evaluated in the local lab): total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution or ≤ 5 in case of liver metastasis); Adequate renal function (evaluated in the local lab): creatinine clearance of at least 40 ml/min; Adequate endocrine (TSH, FT4) function, local guidelines The patient is capable of complying with study procedures; Life expectancy of at least 12 weeks; Negative serum pregnancy test for females of childbearing potential. Signed and dated written informed consent. Ability to comply with contraception requirements

You may not qualify if:

• More than 10 metastatic lesions. More than 2 brain metastatic lesions. 2 brain metastases with a cumulative diameter larger than 5 cm. Patients with non-infectious pneumonitis, uncontrolled thyroid disease, pleuritis, pericarditis and peritonitis carcinomatosis.
• Patients who received live vaccines 30 days or fewer prior to enrolment. Patients who are already actively participating in another study. Patients who need simultaneous radiation on the primary tumour and metastatic lesion(s). For these patients it might be an option to treat the primary tumour first although this is not mandatory for this study. There must be minimal four weeks between last treatment and randomisation.
• Whole brain radiotherapy (WBRT) is not allowed, although it is accepted when given at least 4 weeks prior to randomisation or after the treatment period. Patients with stable brain metastases are not excluded.
• Previous radiotherapy to an area that would be re-treated by (SAB)R, resulting in overlap of the high dose areas.
• Maintenance therapy with Anti-PD(L)1 treatment combined with chemotherapy is not allowed during treatment ((SAB)R and L19-IL2 cycles).
• Other active malignancy or malignancy within the last 2 years (except localised skin basal/squamous cell carcinoma, non-muscle invasive carcinoma of the bladder or in situ carcinoma from any site).
• Concomitantly administered glucocorticoids may decrease the activity of IL2 and therefore should be avoided. However, patients who develop life-threatening signs or symptoms may be treated with dexamethasone until toxicity resolves or reduces to an acceptable level (generally grade 1 and 2, however must be based at the research physician's discretion).
• History of allergy to intravenously administered proteins/peptides/antibodies/ radiographic contrast media.
• HIV positive; active HIV infection, or active hepatitis B or C (assessed in local lab).
• Systemic treatment with either corticosteroid (\>10 mg daily prednisone equivalents) or Interferon alpha or immunosuppressive medications within 14 days prior to randomisation. Topical or inhalation steroids are allowed. If a patient needs to take unexpectedly immunosuppressive medication during the trial, it will be allowed but decreasing the dose as soon as possible is strongly advised.
• Prior history of organ transplant, including autologous stem cell transplant. Acute or sub-acute coronary syndromes within the last year, acute inflammatory heart disease, heart insufficiency NYHA \> 2, or irreversible cardiac arrhythmias.
• A known impaired cardiac function defined as left ventricular ejection fraction (LVEF) \< 50 % (or below the study site's lower limit of normal) as measured by MUGA or ECHO.
• Uncontrolled hypertensive disease; (systolic blood pressure (SBP) ≥160 or diastolic blood pressure (DBP) ≥100 mm Hg during two measurements).
• History or evidence of active autoimmune disease. Severe diabetic retinopathy (neoangiogenesis targeted by L19 outside the tumour).
• Major trauma, including oncologic surgery, but excluding smaller procedures like the placement of porth-à-cath or surgical biopsy, within 4 weeks prior to randomisation (neoangiogenesis targeted by L19 outside a tumour).

Sponsors & Collaborators

• Maastricht University: lead

Related Links

• Website of ImmunoSABR trial
• Page of ImmunoSABR phase 2 trial on Clinicaltrials.gov

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Lambin, Prof. MD

  MUMC/UM

  STUDY DIRECTOR

Central Study Contacts

Iva Halilaj, Msc

CONTACT

+31 (0)43 3883549; i.halilaj@maastrichtuniversity.nl

Relinde Lieverse, MD

CONTACT

immunosabr@maastrichtuniversity.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 27, 2020
• Study Start: October 20, 2020
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 27, 2020

Record last verified: 2020-10